- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03198208
Intraoperative Fentanyl Dose on Respiratory Complications
Effects of Intraoperative Fentanyl Dose on Postoperative Respiratory Complications
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Our team has conducted a series of studies to define the optimal anesthesia plan that minimizes the risk of postoperative respiratory complications. Opioids are almost always used in the perioperative management of patients undergoing surgery during anesthesia. Intraoperatively they are administered to achieve adequate surgical conditions. Opioids are respiratory depressants. They decrease dose-dependently the drive to the respiratory pump muscles and upper airway dilator muscles, which leads to respiratory acidemia and hypercapnia. Fentanyl is the most commonly used opioid during anesthesia at MGH. Compared to other opioids, e.g. sulfentanil and remifentanil, fentanyls pharmacokinetic is more problematic as the context sensitive half-life increases with duration of fentanyl administration. This may lead to respiratory complications. Considering the common use of fentanyl during surgery and its duration of action that is hard to predict during long surgical procedures, we will evaluate the association between intraoperative fentanyl dose and postoperative respiratory complications within 3 days of surgery.
To account for other factors that may affect the incidence of postoperative respiratory complications, we included the following confounder model in all of our analyses:
- Gender
- Age
- BMI (body mass index)
- ASA status classification
- CCI (Charlson Comorbidity Index)
- Inhalational anesthetics as MAC
- Long lasting opioids as IV-morphine milligram equivalent including morphine, hydromorphone, methadone and sufentanil.
- Use of neuraxial anesthesia
- Intraoperative vasopressor dose
- Intraoperative NMBA (neuromuscular blocking agent) dose
- Intraoperative hypotension as number of minutes of an MAP (mean arterial pressure) <55 mmHG
- Duration of surgery
- Emergency status
- Intraoperative fluids
- PRBC (packed red blood cells) units
- Work RVU [relative value unit]
- Surgical service
- Admission type (ambulatory vs inpatient)
- SPORC (Score for Prediction of Postoperative Respiratory Complications)
- SPOSA (Score for Prediction of Obstructive Sleep Apnea)
- Inspiratory O2 - Fraction
- Protective ventilation (defined as PEEP=5 and plateau pressure between 0 and 16)
- Perioperative naloxone use
- Prescription of any of the following opioids within 90 days prior to surgery: oxycodone, codeine, hydrocodone, buprenorphine, butorphanol, opium, hydromorphone, fentanyl, meperidine, morphine, levorphanol, methadone, nalbuphine, tapentadol, oxymorphone, roxicodone, tramadol
- Code status (DNR)
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02114
- The Massachusetts General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Surgical patients at Massachusetts General Hospital and two affiliated community hospitals
- 18 years of age and older
- Only patients who required general anesthesia with an endotracheal tube for the surgical procedure and were extubated in the operating room at the end of the procedure.
Exclusion Criteria:
- Brain dead patients (ASA greater than 5)
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Reference group
No fentanyl dose administered during surgery
|
|
Comparative group
Fentanyl dose administered during surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative respiratory complications
Time Frame: Between the day of surgery and the third day after surgery
|
New postoperative respiratory complications occuring within 3 days after surgery
|
Between the day of surgery and the third day after surgery
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-extubation desaturation
Time Frame: Immediately after endotracheal extubation at the end of surgery
|
Oxygen saturation below 80% and 90% measured immediately after endotracheal extubation
|
Immediately after endotracheal extubation at the end of surgery
|
Non-invasive ventilation
Time Frame: Between the day of surgery and the third day after surgery
|
Incidence of non-invasive ventilation after surgery
|
Between the day of surgery and the third day after surgery
|
ICU admission rate
Time Frame: Between day of surgery and hospital discharge, may be up to one year
|
Admission to the ICU after surgery
|
Between day of surgery and hospital discharge, may be up to one year
|
Hospital length of stay
Time Frame: Number of days between day of hospital admission and hospital discharge, may be up to one year
|
Total duration of hospitalized days
|
Number of days between day of hospital admission and hospital discharge, may be up to one year
|
Total hospital costs
Time Frame: Between day of hospital admission and hospital discharge, may be up to one year
|
Total costs for hospital stay
|
Between day of hospital admission and hospital discharge, may be up to one year
|
Wound infection
Time Frame: Between the day of surgery and 30 days after surgery
|
Incidence of wound infection after surgery
|
Between the day of surgery and 30 days after surgery
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Ruscic KJ, Grabitz SD, Rudolph MI, Eikermann M. Prevention of respiratory complications of the surgical patient: actionable plan for continued process improvement. Curr Opin Anaesthesiol. 2017 Jun;30(3):399-408. doi: 10.1097/ACO.0000000000000465.
- Thevathasan T, Shih SL, Safavi KC, Berger DL, Burns SM, Grabitz SD, Glidden RS, Zafonte RD, Eikermann M, Schneider JC. Association between intraoperative non-depolarising neuromuscular blocking agent dose and 30-day readmission after abdominal surgery. Br J Anaesth. 2017 Oct 1;119(4):595-605. doi: 10.1093/bja/aex240.
- de Jong MAC, Ladha KS, Vidal Melo MF, Staehr-Rye AK, Bittner EA, Kurth T, Eikermann M. Differential Effects of Intraoperative Positive End-expiratory Pressure (PEEP) on Respiratory Outcome in Major Abdominal Surgery Versus Craniotomy. Ann Surg. 2016 Aug;264(2):362-369. doi: 10.1097/SLA.0000000000001499.
- Ladha K, Vidal Melo MF, McLean DJ, Wanderer JP, Grabitz SD, Kurth T, Eikermann M. Intraoperative protective mechanical ventilation and risk of postoperative respiratory complications: hospital based registry study. BMJ. 2015 Jul 14;351:h3646. doi: 10.1136/bmj.h3646.
- Shin CH, Grabitz SD, Timm FP, Mueller N, Chhangani K, Ladha K, Devine S, Kurth T, Eikermann M. Development and validation of a Score for Preoperative Prediction of Obstructive Sleep Apnea (SPOSA) and its perioperative outcomes. BMC Anesthesiol. 2017 May 30;17(1):71. doi: 10.1186/s12871-017-0361-z.
- Brueckmann B, Villa-Uribe JL, Bateman BT, Grosse-Sundrup M, Hess DR, Schlett CL, Eikermann M. Development and validation of a score for prediction of postoperative respiratory complications. Anesthesiology. 2013 Jun;118(6):1276-85. doi: 10.1097/ALN.0b013e318293065c.
- Friedrich S, Raub D, Teja BJ, Neves SE, Thevathasan T, Houle TT, Eikermann M. Effects of low-dose intraoperative fentanyl on postoperative respiratory complication rate: a pre-specified, retrospective analysis. Br J Anaesth. 2019 Jun;122(6):e180-e188. doi: 10.1016/j.bja.2019.03.017. Epub 2019 Apr 11.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017P000825
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
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.
Clinical Trials on Surgery
-
3MRecruitingAbdominal Surgery | Orthopedic Surgery | Vascular Surgery | Cardiovascular SurgeryUnited States
-
Vanderbilt UniversityCompletedHand Surgery | Wrist Surgery | Forearm Surgery | Elbow SurgeryUnited States
-
Nantes University HospitalCompletedGynecological Surgery | Plastic Surgery | ENT SurgeryFrance
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
Maquet Cardiopulmonary GmbHNAMSARecruitingCardiac Surgery | Cardiopulmonary Bypass | Thoracic Surgery | Vascular SurgerySpain
-
Baylor Research InstituteChiesi USA, Inc.RecruitingSurgery | Cardiac Surgery | Surgery--Complications | Percutaneous Coronary InterventionUnited States
-
Vanderbilt UniversityEdwards LifesciencesCompletedCardiac Surgery | Thoracic Surgery | Heart Surgery | Heart Transplant
-
Poudre Valley Health SystemTerminatedSurgery | Surgery--ComplicationsUnited States
-
EgymedicalpediaCompletedSurgery | Pediatric SurgeryEgypt
-
Cairo UniversityBatterjee Medical College; Taif UniversityCompletedSurgery | Bariatric SurgeryEgypt, Saudi Arabia
Clinical Trials on Fentanyl dose administration
-
J2H BiotechCompletedNon-alcoholic SteatohepatitisKorea, Republic of
-
J2H BiotechCompletedNon-alcoholic SteatohepatitisKorea, Republic of
-
University Hospital, GhentCompletedAdvanced Colorectal CancerBelgium
-
Ohio State UniversityRecruiting
-
Forest LaboratoriesCompletedGeneralized Anxiety DisorderUnited States
-
Rockefeller UniversityUniversity of CologneCompletedHealthy | HIVGermany, United States
-
Stanford UniversityThe Gerber FoundationCompletedNeurodevelopmental Disorders | Congenital Heart Disease | Anesthesia; Adverse EffectUnited States
-
Tel-Aviv Sourasky Medical CenterUnknownAspiration | Effects of; Anesthesia, Spinal and Epidural, in PregnancyIsrael
-
Rockefeller UniversityBrigham and Women's Hospital; Weill Medical College of Cornell University; University...CompletedHealthy | HIVUnited States, Germany
-
Yonsei UniversityCompletedEmergence AgitationKorea, Republic of