- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05172739
Opioid Free Anaesthesia-Analgesia Strategy on Surgical Stress and Immunomodulation in Elective VATS-Lobectomy for NSCLC
Effect of a Perioperative Opioid Free Anaesthesia-Analgesia (OFA-A) Strategy on Surgical Stress Response and Immunomodulation in Elective VATS Lobectomy for NSCLC Lung Cancer: A Prospective Randomized Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Surgical manipulation and one lung ventilation (OLV) exert different and synergic effects to generate an inflammatory response during lung resection surgery. Surgery, such as lobectomies, often leads to severe immunosuppression that in turn can lead to infectious complications and sepsis. Both anesthesia-related and surgery-related perioperative measures may modulate the patient's immune response and lead to the activation of different components of the immune system. Anesthesia-induced activation, in particular of the adaptive immune system, may also induce persistent, postoperative immunosuppression. An overwhelming immune cell recruitment may lead to excessive tissue damage, peripheral organ injury and immunoparesis.
Opioid analgesia remains the corner stone of acute pain management in perioperative analgesic regimes. Opioid receptors are not only expressed in the central nervous system to regulate pain perception but also occur on immune and tumour cells. Exogenous opioid administration has been correlated with immunosuppression, opioid-induced hyperalgesia, and respiratory depression, with deleterious outcomes.
An Opioid-Free Anaesthesia-Analgesia (OFA-A) strategy is based on the administration of a variety of anaesthetic/analgesic and other pharmacological agents with different mechanisms of action, including immunomodulating and anti-inflammatory effects where at least one factor causes inhibition of central sensitization and at least another factor inhibits the peripheral sensitization of the nervous system, as a response to painful surgical stimuli. This combination of factors has to have a synergistic or additive effect so that best analgesic effects can be achieved with the lowest possible dosage.
Our basic hypothesis is that a perioperative OFA-A strategy on cancer patients undergoing VATS lung surgery for tumour resection will be accompanied by abolished or attenuated immunosuppression. The additional potential clinical implication of a perioperative OFA-A strategy is the avoidance of the onco-proliferative side effects of both exogenous and endogenous opioids, released by cytokine-mediated immune cell activation. Inflammatory response inhibition is expected to reduce the possibility of acute and chronic post-operative pain developement, compared to a perioperative Opioid-Based Anaesthesia- Analgesia (OBA-A) technique. Additionally, the aforementioned inflammatory response inhibition is expected to lead to an overall reduction of overall postoperative pulmonary complications.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Periklis Vasilos, MD
- Phone Number: 00306978702023
- Email: p.vassilos@gmail.com
Study Contact Backup
- Name: Georgios Stefanakis, MD, PhD
- Phone Number: 00306978779726
- Email: G_Stefanakis@yahoo.com
Study Locations
-
-
Crete
-
Heraklion, Crete, Greece, 71110
- Recruiting
- University of Crete
-
Contact:
- Periklis Vasilos, MD
- Phone Number: 00306978702023
- Email: p.vassilos@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- patients undergoing elective VATS lobectomy
- early stage NSCLC (up to T3N1M0)
Exclusion Criteria:
- Immunocompromised patients
- previous lung surgery
- preoperative corticosteroid or immunosuppressive drug use
- uncontrolled Diabetes Mellitus
- cardiac failure (NYHA 3 and 4)
- preoperative infection (CRP >5mg/ml, WBC >10x10^9/L)
- preoperative anemia (Hb<12g/dl)
- chronic inflammatory diseases
- inflammatory bowel disease
Group-specific exclusion criteria:
- OFA-Α: perioperative opioid administration, within the study period
- OBA-Α: perioperative dexmedetomidine or lidocaine infusion, ketamine, gabapentinoid or corticosteroid administration within the study period
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Opioid-Based Anaesthesia Analgesia
Premedication: IM Midazolam 0.05-0.07mg/kg.
Anesthesia induction: Midazolam 0.03mg/kg, Propofol 2-3mg/kg, Fentanyl 1-2mcg/kg and Cisatracurium 0.2mg/kg or alternatively Rocuronium 0.6-1.2mg/
kg.
Anesthesia maintenance: Desflurane set at approximately 1 MAC, Morphine 0.1-0.12mg/kg,
Fentanyl 1-2mcg/kg during induction and 50-100mcg prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, along with Ondansetron 4mg or Droperidol 0.625mg.
Wound infiltration: Ropivacaine 75-150mg.
Surgical ward: PCA pump with Morphine for the first 3 postoperative days.
Additional postoperative analgesia: Paracetamol 1g 1x3 +/- Dexketoprofen trometamol 50mg 1x2.
Rescue therapy only: Tramadol 50-100mg.
|
A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents: Premedication: Midazolam, Anaesthesia induction & maintenance: Midazolam, Propofol, Fentanyl, Cisatracurium or alternatively Rocuronium, Desflurane, Morphine, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine Surgical ward: Morphine, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol
Other Names:
|
Active Comparator: Opioid-Free Anesthesia Analgesia
Premedication: Pregabalin 150mg 1x2, IM Midazolam 0.05-0.07mg/kg.
Anesthesia induction: Midazolam 0.03mg/kg, Dexmedetomidine 0.5-1mcg/kg, Lidocaine 1mg/kg, Propofol 2-3mg/kg, Ketamine 1-1.5mg/kg,
Hyoscine 10mg, Cisatracurium 0.2mg/ kg or alternatively Rocuronium 0.6-1.2mg/kg,
Magnesium sulphate 2.5-5g and Dexamethasone 8-16mg.
Anesthesia maintenance: Desflurane set at ~1 MAC, Dexmedetomidine 0.5-1.2mcg/kg/h,
Lidocaine 0.5-1mg/kg/h, Ketamine 0.3-0.5mg/kg
prn, Paracetamol 1g +/- Dexketoprofen trometamol 50mg, and Ondansetron 4mg or Droperidol 0.625mg.
Wound infiltration: Ropivacaine 75-150mg.
Surgical ward: PCA pump with Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam for the first 3 postoperative days.
Additionally, Pregabalin 50mg per os 1x1 and 25mg 1x1, Paracetamol 1g 1x3 +/- Dexketoprofen trometamol 50mg 1x2.
Rescue therapy only: Tramadol 50-100mg.
|
A perioperative Opioid-Based multimodal Anesthesia- Analgesia strategy will be implemented that incorporates the following pharmacological agents: Premedication: Pregabalin, Midazolam, Anesthesia induction & maintenance: Midazolam, Dexmedetomidine, Lidocaine, Propofol, Ketamine, Hyoscine, Cisatracurium or alternatively Rocuronium, Magnesium sulphate, Dexamethasone, Desflurane, Paracetamol, Dexketoprofen trometamol, Ondansetron or Droperidol, Ropivacaine, Surgical ward: Ketamine, Lidocaine, Clonidine, Droperidol and Midazolam, Pregabalin, Paracetamol, Dexketoprofen trometamol Rescue therapy only: Tramadol
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neutrophil to Lymphocyte ratio (NLR)
Time Frame: Preoperatively
|
Neutrophil to Lymphocyte ratio (NLR) is a prognostic index that predicts patients' overall survival.
Higher NLR has been correlated with worse outcome.
|
Preoperatively
|
Platelet to Lymphocyte ratio (PLR)
Time Frame: Preoperatively
|
Platelet to Lymphocyte ratio (PLR) is a prognostic index that predicts patients' overall survival.
Higher PLR has been correlated with worse outcome.
|
Preoperatively
|
Lymphocyte to monocyte ratio (LMR)
Time Frame: Preoperatively
|
Lymphocyte to monocyte ratio (LMR) is a prognostic index that predicts patients' overall survival.
Lower LMR has been correlated with worse outcome.
|
Preoperatively
|
Advanced Lung Cancer Inflammation Index (ALI)
Time Frame: Preoperatively
|
Advanced Lung Cancer Inflammation Index (ALI) is a prognostic index that predicts patients' recurrence-free survival and overall survival.
ALI is calculated as (BMI x Alb / NLR) where BMI = body mass index, Alb = serum albumin, NLR (neutrophil lymphocyte ratio, a marker of systemic inflammation).
Higher ALI scores have been correlated with worse outcome.
|
Preoperatively
|
Systemic Immune Inflammation Index (SII)
Time Frame: Preoperatively
|
Systemic Immune Inflammation Index (SII) is a prognostic index that predicts patients' overall survival.
SII is calculated as follows: SII = platelet count × neutrophil/lymphocyte count.
Higher SII scores have been correlated with worse outcome.
|
Preoperatively
|
Prognostic Nutritional Index (PNI)
Time Frame: Preoperatively
|
Prognostic Nutritional Index (PNI) is a prognostic index that predicts patients' overall survival.
PNI is calculated as follows: PNI = 10 × serum albumin value (g/dL) + 0.005 × total lymphocyte count (per mm3) in the peripheral blood.
Higher PNI scores have been correlated with worse outcome.
|
Preoperatively
|
Surgical Stress Response - IL-6 - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by IL-6 serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - IL-6 - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by IL-6 serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - IL-6 - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by IL-6 serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - IL-8 - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by IL-8 serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - IL-8 - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by IL-8 serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - IL-8 - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by IL-8 serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - IL-10 - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by IL-10 serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - IL-10 - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by IL-10 serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - IL-10 - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by IL-10 serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - TNF-a - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by TNF-a serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - TNF-a - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by TNF-a serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - TNF-a - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by TNF-a serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - CRP - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by CRP serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - CRP - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by CRP serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - CRP - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by CRP serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - WBC - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by WBC count.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - WBC - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by WBC count.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - WBC - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by WBC count.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - AVP - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by AVP serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - AVP - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by AVP serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - AVP - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by AVP serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - cortisol - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by cortisol serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - cortisol - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by cortisol serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - cortisol - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by cortisol serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - HIF-1α- preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by HIF-1α serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - HIF-1α - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by HIF-1α serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - HIF-1α - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by HIF-1α serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - VEGF- preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by VEGF serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - VEGF- end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by VEGF serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - VEGF - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by VEGF serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - NF-κB - preoperatively
Time Frame: Preoperatively (as a baseline)
|
Inflammatory response and stress response as quantified by NF-κB serum levels.
Blood sample collection will take place in both study groups
|
Preoperatively (as a baseline)
|
Surgical Stress Response - NF-κB - end of surgery
Time Frame: End of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by NF-κB serum levels.
Blood sample collection will take place in both study groups
|
End of surgery (end of placement of last suture/ surgical clip on patient)
|
Surgical Stress Response - NF-κB - 24 hours after the end of surgery
Time Frame: 24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Inflammatory response and stress response as quantified by NF-κB serum levels.
Blood sample collection will take place in both study groups
|
24 hours after the end of surgery (end of placement of last suture/ surgical clip on patient)
|
Haemodynamic Stability - Mean PR
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean PR will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum PR
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum PR will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum PR
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum PR will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation PR
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate - PR. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation PR will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - PR Change Induction
Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after anesthesia induction, compared to 1 minute prior.
Data will be collected from a pulse contour analysis monitor.
|
1 minute after anesthesia induction, compared to 1 minute prior
|
Haemodynamic Stability - PR Change Incision
Time Frame: 1 minute after surgical incision, compared to 1 minute prior
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Pulse Rate change 1 minute after surgical incision, compared to 1 minute prior.
Data will be collected from a pulse contour analysis monitor.
|
1 minute after surgical incision, compared to 1 minute prior
|
Haemodynamic Stability - Mean SBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean SBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum SBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum SBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum SBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum SBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation SBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure - SBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation SBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - SBP Change Induction
Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior.
Data will be collected from a pulse contour analysis monitor.
|
1 minute after anesthesia induction, compared to 1 minute prior
|
Haemodynamic Stability - SBP Change Incision
Time Frame: 1 minute after surgical incision, compared to 1 minute prior
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Systolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior.
Data will be collected from a pulse contour analysis monitor.
|
1 minute after surgical incision, compared to 1 minute prior
|
Haemodynamic Stability - Mean DBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean DBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum DBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum DBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum DBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum DBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation DBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure - DBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation DBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - DBP change induction
Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior.
Data will be collected from a pulse contour analysis monitor.
|
1 minute after anesthesia induction, compared to 1 minute prior
|
Haemodynamic Stability - DBP change incision
Time Frame: 1 minute after surgical incision, compared to 1 minute prior
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Diastolic Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior.
Data will be collected from a pulse contour analysis monitor.
|
1 minute after surgical incision, compared to 1 minute prior
|
Haemodynamic Stability - Mean MBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean MBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum MBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum MBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum MBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum MBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation MBP
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure - MBP.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation MBP will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - MBP change induction
Time Frame: 1 minute after anesthesia induction, compared to 1 minute prior
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after anesthesia induction, compared to 1 minute prior.
Data will be collected from a pulse contour analysis monitor.
|
1 minute after anesthesia induction, compared to 1 minute prior
|
Haemodynamic Stability - MBP change incision
Time Frame: 1 minute after surgical incision, compared to 1 minute prior
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Mean Blood Pressure change 1 minute after surgical incision, compared to 1 minute prior.
Data will be collected from a pulse contour analysis monitor.
|
1 minute after surgical incision, compared to 1 minute prior
|
Haemodynamic Stability - Mean CO
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean CO will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum CO
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum CO will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum CO
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum CO will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation CO
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Output - CO. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation CO will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Mean CI
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean CI will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum CI
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum CI will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum CI
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum CI will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation CI
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Cardiac Index - CI. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation CI will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Mean SV
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean SV will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum SV
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum SV will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum SV
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum SV will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation SV
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume - SV. Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation SV will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Mean SVV
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean SVV will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum SVV
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum SVV will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum SVV
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum SVV will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation SVV
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Variation - SVV.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation SVV will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Mean SVI
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Mean SVI will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Minimum SVI
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Minimum SVI will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Maximum SVI
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Maximum SVI will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Standard Deviation SVI
Time Frame: Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Stroke Volume Index - SVI.
Data will be collected from a pulse contour analysis monitor, and values will be collected every 20 seconds.
Standard Deviation SVI will be reported for each patient, extracted from the collected data.
|
Every 20 seconds from anesthesia induction, until the end of surgery (end of placement of last suture/ surgical clip on patient), assessed up to 8 hours]
|
Haemodynamic Stability - Tachycardia
Time Frame: Intraoperatively, assessed up to 4 hours.
|
Intraoperative Tachycardia (defined as PR≥ 100 bpm), with episodes lasting ≥1 minute.
Data will be reported in total seconds of intraoperative tachycardia.
|
Intraoperatively, assessed up to 4 hours.
|
Haemodynamic Stability - Bradycardia
Time Frame: Intraoperatively, assessed up to 4 hours.
|
Intraoperative Bradycardia (defined as PR≤ 60 bpm), with episodes lasting ≥1 minute.
Data will be reported in total seconds of intraoperative bradycardia.
|
Intraoperatively, assessed up to 4 hours.
|
Haemodynamic Stability - Hypotension
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Intraoperative Hypotension (defined as SBP≤100mmHg or ≤70% of preoperative Baseline), with episodes lasting ≥1 minute.
All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds.
Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline.
Data will be reported in total seconds of intraoperative hypotension.
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Hypertension
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Intraoperative Hypertension (defined as SBP ≥130% of preoperative Baseline), with episodes lasting ≥1 minute.
All patients will have a 5 minute preoperative SBP baseline, with measurements every 20 seconds.
Intraoperative data will be compared to the mean preoperative 5 minute SPB baseline.
Data will be reported in total seconds of intraoperative hypertension.
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Fluid requirements - Crystalloids - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Crystalloid Fluid Requirements.
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Fluid requirements - Colloids - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Colloid Fluid Requirements.
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Fluid requirements - Concentrated RBCs - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Concentrated Red Blood Cell unit Requirements.
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Fluid requirements - Plasma - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Plasma unit Requirements.
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Fluid requirements - Platelets - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Platelet unit Requirements.
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Blood Loss - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Blood Loss
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Fluid Balance - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Fluid Balance
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Vasoactive Requirements - Adrenaline - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Adrenaline requirements
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Vasoactive Requirements - Noradrenaline - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Noradrenaline requirements
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Vasoactive Requirements - Ephedrine - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Ephedrine requirements
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Vasoactive Requirements - Phenylephrine - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Phenylephrine requirements
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Vasoactive Requirements - Dopamine - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dopamine requirements
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Vasoactive Requirements - Dobutamine - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Dobutamine requirements
|
Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability - Vasoactive Requirements - Nitroglycerine - Intraoperatively
Time Frame: Intraoperatively, assessed up to 6 hours.
|
Haemodynamic Stability as quantified by hemodynamic markers, specifically Nitroglycerine requirements
|
Intraoperatively, assessed up to 6 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute postoperative pain - Numerical Rating Scale (NRS) - Immediately Postoperatively
Time Frame: Immediately postoperatively
|
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS).
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
|
Immediately postoperatively
|
Acute postoperative pain - Numerical Rating Scale (NRS) - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS).
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
|
First postoperative day
|
Acute postoperative pain - Numerical Rating Scale (NRS) - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS).
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
|
Second postoperative day
|
Acute postoperative pain - Numerical Rating Scale (NRS) - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Numerical Rating Scale (NRS).
The 11-point numeric scale ranges from '0' representing one pain extreme (e.g.
"no pain") to '10' representing the other pain extreme (e.g.
"pain as bad as you can imagine" or "worst pain imaginable").
|
Third postoperative day
|
Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Immediately Postoperatively
Time Frame: Immediately postoperatively
|
Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT).
The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients.
Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
|
Immediately postoperatively
|
Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT).
The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients.
Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
|
First postoperative day
|
Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT).
The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients.
Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
|
Second postoperative day
|
Acute postoperative pain - Critical Care Pain Observation Tool (CPOT) - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Critical Care Pain Observation Tool (CPOT).
The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients or vocalization for extubated patients.
Patient's behavior in each domain is scored between 0 and 2. The possible total score ranges from 0 (no pain) to 8 (maximum pain).
|
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Intolerable" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Intolerable" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Intolerable - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Intolerable" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Tolerable with discomfort - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Tolerable with Discomfort" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Comfortably manageable" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Comfortably manageable" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Comfortably manageable - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Comfortably manageable" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Negligible Pain" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Negligible Pain" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Comfort - Negligible Pain - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to how comfortable patients feel with their pain, available answers will be:
The percentage of patients that report pain that is "Negligible Pain" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "Getting worse" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "Getting worse" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting Worse - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "Getting worse" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "About the same" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "About the same" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - About the same - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "About the same" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "Getting Better" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "Getting Better" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Change in Pain - Getting better - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to changes in pain perception by patients, available answers will be:
The percentage of patients that report pain that is "Getting Better" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Inadequate pain control" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Inadequate pain control" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Inadequate pain control - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Inadequate pain control" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Effective, just about right" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Effective, just about right" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Effective, just about right - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Effective, just about right" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Would like to reduce medication" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Would like to reduce medication" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Pain control - Would like to reduce medication - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to pain control reported by patients, available answers will be:
The percentage of patients that report "Would like to reduce medication" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can't do anything because of pain - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can't do anything because of pain" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Pain keeps me from doing most of what I need to do - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Pain keeps me from doing most of what I need to do" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do most things, but pain gets in the way of some - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can do most things, but pain gets in the way of some" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Functioning - Can do everything I need to do - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to functioning - for the usual things patients need to do, available answers will be:
The percentage of patients whose functioning is reported as "Can do everything I need to do" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with pain most of the night - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as "Awake with pain most of the night" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Awake with occasional pain - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as " Awake with occasional pain" will be reported |
Third postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as "Normal sleep" will be reported |
First postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as "Normal sleep" will be reported |
Second postoperative day
|
Acute postoperative pain - Clinically Aligned Pain Assessment Tool (CAPA) - Sleep - Normal sleep - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain using scales: Clinically Aligned Pain Assessment Tool (CAPA). Patients will be given a standardized CAPA questionaire that has pre-determined answers that patients will be able to choose from, to best describe their pain. In regards to sleep, if the pain is waking patients up, available answers will be:
The percentage of patients whose sleep is reported as "Normal sleep" will be reported |
Third postoperative day
|
Analgesic Requirements - First postoperative day
Time Frame: First postoperative day
|
Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
|
First postoperative day
|
Analgesic Requirements - Second postoperative day
Time Frame: Second postoperative day
|
Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
|
Second postoperative day
|
Analgesic Requirements - Third postoperative day
Time Frame: Third postoperative day
|
Evaluation of patients' pain by recording the number of times that rescue analgesia (tramadol) was required.
|
Third postoperative day
|
Postoperative Pulmonary Complications - Aspiration Pneumonitis
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Aspiration pneumonitis (defined as respiratory failure after the inhalation of regurgitated gastric contents)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Moderate respiratory failure
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Moderate respiratory failure (SpO2 < 90% or PaO2 < 60 mmHg for 10 min in room air, responding to oxygen > 2 L/min)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Severe respiratory failure
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Severe respiratory failure (need for non-invasive or invasive mechanical ventilation due to poor oxygenation)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - ARDS
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Adult respiratory distress syndrome (mild, moderate, or severe according to the Berlin definition)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Pulmonary Infection
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Pulmonary infection (defined as new or progressive radiographic infiltrate plus at least two of the following: antibiotic treatment, tympanic temperature > 38 °C, leukocytosis or leucopenia (white blood cell (WBC) count < 4000 cells/mm3 or > 12,000 cells/mm3) and/or purulent secretions)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Atelectasis
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Atelectasis (suggested by lung opacification with shift of the mediastinum, hilum, or hemidiaphragm towards the affected area, and compensatory over-inflation in the adjacent non-atelectatic lung)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Cardiopulmonary edema
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Cardiopulmonary edema (defined as clinical signs of congestion, including dyspnea, edema, rales, and jugular venous distention, with the chest x-ray demonstrating increase in vascular markings and diffuse alveolar interstitial infiltrates)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Pleural effusion
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Pleural effusion (chest x-ray demonstrating blunting of the costophrenic angle, loss of the sharp silhouette of the ipsilateral hemidiaphragm in upright position, evidence of displacement of adjacent anatomical structures, or (in supine position) a hazy opacity in one hemithorax with preserved vascular shadows)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Pneumothorax
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Pneumothorax (defined as air in the pleural space with no vascular bed surrounding the visceral pleura)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Pulmonary Infiltrates
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Pulmonary infiltrates (chest x-ray demonstrating new monolateral or bilateral infiltrate without other clinical signs)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Prolonged air leakage
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Prolonged air leakage (air leak requiring at least 7 days of postoperative chest tube drainage)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Purulent pleuritic
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Purulent pleuritic (receiving antibiotics for a suspected infection, as far as not explained by the preoperative patient condition alone)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Pulmonary embolism
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Pulmonary embolism (as documented by pulmonary arteriogram or autopsy, or supported by ventilation/perfusion radioisotope scans, or documented by echocardiography and receiving specific therapy)
|
From the first postoperative day, until the fifth postoperative day
|
Postoperative Pulmonary Complications - Lung hemorrhage
Time Frame: From the first postoperative day, until the fifth postoperative day
|
Lung hemorrhage (bleeding through the chest tubes requiring reoperation, or three or more red blood cell packs)
|
From the first postoperative day, until the fifth postoperative day
|
Chronic postoperative pain - Pain Detect
Time Frame: Three months after the end of surgery
|
Evaluation of patients' pain using the standardized "Pain Detect" questionnaire.
The "Pain Detect" questionnaire has been standardized for screening the presence of a neuropathic pain component.
Patients will be interviewed by phone interview, 3 months after the end of surgery.
The possible score a patient can have, ranges from 0 to 38.
|
Three months after the end of surgery
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Vasileia Nyktari, MD, PhD, University of Crete, Medical School
Publications and helpful links
General Publications
- Sanchez-Pedrosa G, Vara Ameigeiras E, Casanova Barea J, Rancan L, Simon Adiego CM, Garutti Martinez I. Role of surgical manipulation in lung inflammatory response in a model of lung resection surgery. Interact Cardiovasc Thorac Surg. 2018 Dec 1;27(6):870-877. doi: 10.1093/icvts/ivy198.
- Schneemilch CE, Hachenberg T, Ansorge S, Ittenson A, Bank U. Effects of different anaesthetic agents on immune cell function in vitro. Eur J Anaesthesiol. 2005 Aug;22(8):616-23. doi: 10.1017/s0265021505001031.
- Homburger JA, Meiler SE. Anesthesia drugs, immunity, and long-term outcome. Curr Opin Anaesthesiol. 2006 Aug;19(4):423-8. doi: 10.1097/01.aco.0000236143.61593.14.
- Kurosawa S, Kato M. Anesthetics, immune cells, and immune responses. J Anesth. 2008;22(3):263-77. doi: 10.1007/s00540-008-0626-2. Epub 2008 Aug 7.
- Calogero AE, Norton JA, Sheppard BC, Listwak SJ, Cromack DT, Wall R, Jensen RT, Chrousos GP. Pulsatile activation of the hypothalamic-pituitary-adrenal axis during major surgery. Metabolism. 1992 Aug;41(8):839-45. doi: 10.1016/0026-0495(92)90164-6.
- Ninkovic J, Roy S. Role of the mu-opioid receptor in opioid modulation of immune function. Amino Acids. 2013 Jul;45(1):9-24. doi: 10.1007/s00726-011-1163-0. Epub 2011 Dec 15.
- Kosciuczuk U, Knapp P, Lotowska-Cwiklewska AM. Opioid-induced immunosuppression and carcinogenesis promotion theories create the newest trend in acute and chronic pain pharmacotherapy. Clinics (Sao Paulo). 2020 Mar 23;75:e1554. doi: 10.6061/clinics/2020/e1554. eCollection 2020.
- Plein LM, Rittner HL. Opioids and the immune system - friend or foe. Br J Pharmacol. 2018 Jul;175(14):2717-2725. doi: 10.1111/bph.13750. Epub 2017 Mar 23.
- Vallejo R, de Leon-Casasola O, Benyamin R. Opioid therapy and immunosuppression: a review. Am J Ther. 2004 Sep-Oct;11(5):354-65. doi: 10.1097/01.mjt.0000132250.95650.85.
- Finley MJ, Happel CM, Kaminsky DE, Rogers TJ. Opioid and nociceptin receptors regulate cytokine and cytokine receptor expression. Cell Immunol. 2008 Mar-Apr;252(1-2):146-54. doi: 10.1016/j.cellimm.2007.09.008. Epub 2008 Feb 14.
- Parkhill AL, Bidlack JM. Reduction of lipopolysaccharide-induced interleukin-6 production by the kappa opioid U50,488 in a mouse monocyte-like cell line. Int Immunopharmacol. 2006 Jun;6(6):1013-9. doi: 10.1016/j.intimp.2006.01.012. Epub 2006 Feb 17.
- Busch-Dienstfertig M, Stein C. Opioid receptors and opioid peptide-producing leukocytes in inflammatory pain--basic and therapeutic aspects. Brain Behav Immun. 2010 Jul;24(5):683-94. doi: 10.1016/j.bbi.2009.10.013. Epub 2009 Oct 29.
- Stein C, Kuchler S. Non-analgesic effects of opioids: peripheral opioid effects on inflammation and wound healing. Curr Pharm Des. 2012;18(37):6053-69. doi: 10.2174/138161212803582513.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Inflammation
- Postoperative Complications
- Pain
- Neurologic Manifestations
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Shock
- Pain, Postoperative
- Lung Neoplasms
- Chronic Pain
- Acute Pain
- Systemic Inflammatory Response Syndrome
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Narcotics
- Anesthetics
- Analgesics, Opioid
Other Study ID Numbers
- OFA-Thoracic
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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ImmunexpressJohns Hopkins University; Northwell Health; Rush University Medical Center; Intermountain... and other collaboratorsCompletedSepsis | Systemic Inflammatory Response Syndrome (SIRS)United States
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Seattle Children's HospitalImmunexpressCompletedSepsis | Systemic Inflammatory Response Syndrome (SIRS)United States
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University of ArkansasTerminatedPediatric Patients With SIRS (Systemic Inflammatory Response Syndrome)United States
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University Hospital, LimogesTerminatedSevere Sepsis | Inflammatory Response Syndrome, SystemicFrance
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Seattle Children's HospitalImmunexpressCompletedSepsis | Non-Infectious Systemic Inflammatory Response SyndromeUnited States
Clinical Trials on Opioid-Based Anesthesia-Analgesia Strategy
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University of CreteUniversity Hospital of CreteRecruitingPostoperative Pain | Anesthesia | Opioid Use | Interleukin 6 | Elective Surgical Procedures | Abdominal Aortic Aneurysm Without Rupture | Vascular Surgical Procedure | ImmunomodulatorsGreece
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University Hospital, BrestRecruitingPulmonary EmbolismFrance, Switzerland
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Children's Hospital of Fudan UniversityCompleted
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The Cleveland ClinicWithdrawn
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University Hospital of SplitCompletedQuality of Life | Analgesia | Anesthesia | Patient Satisfaction | Nephrectomy | Anesthesia Recovery Period | Epidural | Postoperative PeriodCroatia
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Tongji HospitalNot yet recruitingVideo-assisted Thoracoscopic Lung Surgery;Anesthesia
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Muhammad Haroon AnwarPakistan Institute of Medical SciencesRecruiting
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Cardiocentro TicinoUniversity of BernRecruitingChronic Coronary SyndromeSwitzerland
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Grupo Rehabilitacion en SaludInstituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS) and other collaboratorsCompletedDiabetes Mellitus | Lower Limb Amputation Below Knee (Injury) | Lower Limb Amputation Above Knee (Injury) | Rehabilitation | Prosthesis User | Lower Limb Ischemia | Lower Limb Amputation Knee | Clinical Practice GuidelinesColombia
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Columbia UniversityNational Institute on Aging (NIA)RecruitingHealthy AgingUnited States