- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03099616
Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Bariatric Surgery
Automated Closed Loop Propofol Anaesthesia Versus Desflurane Inhalation Anaesthesia In Obese Patients Undergoing Bariatric Surgery: A Comparative Randomized Analysis of Recovery Profile
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
After Institutional Ethics Committee approval and written informed consent, forty-participants (20 per group) aged 18-65 years, ASA physical status I/III, BMI >35-kg/m2, of either sex, and undergoing laparoscopic/robotic bariatric surgery (sleeve gastrectomy or gastric bypass) will be included in this single center (Sir Ganga Ram Hospital, New Delhi-110060, India) prospective, double-blinded, two-arm, randomised controlled study.
The patients who qualify inclusion criteria and consent for recruitment will be randomly divided into one of the two groups:
Group-1 [CLADS Group, n=20]: Anaesthesia will be induced and maintained with Propofol administered using the automated CLADS.
Group-2 [Desflurane Group, n=20]: Anaesthesia will be induced with Propofol administered using the automated CLADS and will be maintained with Desflurane.
Sample-size Estimation
In a previous study, the time-to-eye opening with Desflurane and Propofol was 4.2 minutes and 10.7 minutes, respectively. Based on above, a samples size of 15-patients will be required per group to provide 90% power with a bilateral α-risk value of 0.05 to posit a significant difference in time-to-eye opening. We plan to recruit a total of 40-patients to cover up for unanticipated losses after the recruitment.
Randomization, Allocation Concealment
The patients will be randomly allocated to one of the two groups based on a computer-generated random number table (url:stattrek.com/statistics/random-number-generator.aspx). Randomization sequence concealment will include opaque-sealed envelopes with alphabetic codes whose distribution will be in control of an independent analyst. The envelopes will be opened; patient's data-slip will be pasted on them, and will be sent back to the control analyst.
Blinding Strategy
The attending anaesthesiologist will not be blinded to the technique utilized to administer GA and recovery immediately after extubation inside the OR. However, the postoperative patient recovery profile will be evaluated by an independent assessor blinded to the technique of GA.
Management of Anesthesia
Two peripheral venous lines (18G/20G catheter) will be secured. Standard monitoring (EKG, NIBP, pulse oximeter, EtCO2) will be applied. A BIS sensor (Covidien IIc, Mansfield, USA) will be applied over the patient's forehead according to manufacturer's instruction prior to induction of anaesthesia for monitoring depth of anaesthesia. The BIS monitoring module (Model DSC-XP, Aspect medical system, USA) will facilitate monitoring of anaesthesia depth.
Anaesthesia Technique
All the patients will be administered pre-induction fentanyl-citrate analgesia as per a predefined strategy (total 2-µg/kg IV: 1-µg/kg at 0 minute and 3-minute time point). Pre-oxygenation will be initiated at 3-minute time point or prior to that if there is a fall in oxygen saturation (< 94 percent). In both the groups, at 6-minute time point, anesthesia will be induced with Propofol administered by CLADS. In both the groups CLADS will be set to deliver Propofol according to lean body weight (LBW). A BIS-value of 50 will be used as the target for induction of anesthesia. After induction of anesthesia, atracurium besylate 0.05-mg/kg will be administered for skeletal muscle relaxation to facilitate tracheal intubation. Ventilator settings of CMV, tracheal tube size [7.5-mm I.D (male), 6.5-mm I.D (female)], and breathing circuit (circle-CO2 absorber system) will be the standardized in all the patients. Thereafter, the patients in the CLADS group will receive anaesthesia maintenance with Propofol, with the dosing based on adjusted body weight (ABW), and administration controlled with CLADS tuned to consistent anaesthetic depth (BIS-50) feedback from the patients. The patients in Desflurane group will receive anaesthesia maintenance with Desflurane dial concentration titrated to maintain a BIS of 50-55 in all the patients. Oxygen-air mixture (FiO2 0.50) will be used for ventilation in both the groups.
In addition, starting post-intubation, all the patients will receive 1.0-µg/kg/hr fentanyl infusion for intraoperative analgesia. Intraoperative muscle relaxation will be maintained using atracurium boluses controlled by train-of-four response on peripheral neuromuscular monitor (Infinity TridentNMT Smartpod, Draeger Medical Systems, Inc Telford, USA).
Thirty minutes before the end of surgery, non-opioid analgesics, such as paracetamol 1-gm, and tramadol 100-mg will be administered to the patient. The Propofol or Desflurane delivery will be stopped at the point of completion of skin closure. Residual neuromuscular blockade (assessed with train-of-four response) will be reversed with neostigmine (50-µg/kg) and glycopyrrolate (20-µg/kg).
Thirty minutes before the end of surgery, non-opioid analgesics, such as paracetamol 1-gm, and tramadol 100-mg will be administered to the patient. The Propofol or Desflurane delivery will be stopped at the point of completion of skin closure. Residual neuromuscular blockade (assessed with train-of-four response) will be reversed with neostigmine (50-µg/kg) and glycopyrrolate (20-µg/kg).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110060
- Sir Ganga Ram Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients of age 18-65 years
- BMI > 35 kg/m2
- Either sex
- ASA physical status II & III
- Undergoing laparoscopic/ robotic bariatric surgery
Exclusion Criteria:
- Uncompensated cardiovascular disease (e.g. uncontrolled hypertension, atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance, diastolic dysfunction)
- Hepato-renal insufficiency
- Uncontrolled endocrinology disease (e.g. diabetes mellitus, hypothyroidism)
- Known allergy/hypersensitivity to the study drug
- Pulmonary dysfunction (obstructive/restrictive lung disease)
- Acute/chronic drug dependence/substance abuse
- Requirement of postoperative ventilation
- Refusal to informed consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: CLADS group
Anesthesia will be induced with Propofol administered by CLADSwhich will be set to deliver Propofol according to lean body weight (LBW).
A BIS-value of 50 will be used as the target for induction of anesthesia.
Thereafter anaesthesia maintenance will be done with Propofol, with the dosing based on adjusted body weight (ABW), and administration controlled with CLADS tuned to consistent anaesthetic depth (BIS-50) feedback from the patients.
|
Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.
|
Active Comparator: Desflurane group
Anesthesia will be induced with Propofol administered by CLADSwhich will be set to deliver Propofol according to lean body weight (LBW).
A BIS-value of 50 will be used as the target for induction of anesthesia.Thereafter anaesthesia maintenance will be done with desflurane using an agent specific vaporiser, whose dial concentration will be adjusted to maintain a BIS of 50-55 in all the patients
|
Desflurane delivery will be controlled using a agent specific vaporiser.
The dial concentration of the vaporiser will be adjusted to maintain a BIS of 50-55 in the patients.
Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Early Recovery
Time Frame: From end of anaesthesia till 20-minutes postoperatively
|
Time taken by the patient to open his/her eyes after discontinuation of anaesthesia will be noted
|
From end of anaesthesia till 20-minutes postoperatively
|
Early Recovery
Time Frame: From end of anaesthesia till 30-minutes postoperatively
|
Time taken for tracheal extubation after discontinuation of anaesthesia will be noted
|
From end of anaesthesia till 30-minutes postoperatively
|
Early recovery
Time Frame: From end of anaesthesia till 30-minutes postoperatively
|
Ability of the patient to comprehend instructions for shifting himself/herself from the OR table to the transport bed will be assessed using a 4-point scale
|
From end of anaesthesia till 30-minutes postoperatively
|
Intermediate recovery
Time Frame: From end of anaesthesia till 180-minutes postoperatively
|
Time taken to achieve a modified Aldrete score of 9 or 10
|
From end of anaesthesia till 180-minutes postoperatively
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in intra-operative heart rate (beats per minute)
Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intra-operatively
|
Comparison of intra-operative heart rate between both the arms will be done
|
From beginning of anesthesia (0-hours, baseline) till 6 hours intra-operatively
|
Change in Intra-operative blood pressure - systolic , diastolic, and mean (mmHg)
Time Frame: From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively
|
Comparison of intra-operative blood pressure- systolic, diastolic, and mean between both the arms will be done
|
From beginning of anesthesia (0-hours, baseline) till 6 hours intraoperatively
|
Postoperative Sedation
Time Frame: From end of anaesthesia till 24-hours postoperatively
|
Will be assessed using Modified Observer's assessment of alertness/sedation scale (OASS)
|
From end of anaesthesia till 24-hours postoperatively
|
Postoperative Nausea and Vomiting
Time Frame: From end of anaesthesia till 24-hours postoperatively
|
Will be assessed using PONV Scale
|
From end of anaesthesia till 24-hours postoperatively
|
Postoperative Analgeisa
Time Frame: From end of anaesthesia till 24-hours postoperatively
|
Will be assessed using 10-point Visual Analogue Scale (VAS) Score
|
From end of anaesthesia till 24-hours postoperatively
|
Patient Satisfaction
Time Frame: From end of anaesthesia till 24-hours postoperatively
|
Will be assessed using a 10-point numeric rating scale
|
From end of anaesthesia till 24-hours postoperatively
|
Anesthesia Depth Consistency
Time Frame: From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively]
|
Determined by the percentage of the total anaesthesia time in which the BIS scores remain within a score of 10% of the target BIS (i.e.
BIS-50) and Varvel criteria parameters; median performance error (MDP), median absolute performance error (MDAPE), wobble and global score
|
From beginning of anaesthesia (0-hours, baseline) till 6 hours intraoperatively]
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amitabh Dutta, MD, Sir Ganga Ram Hospital, New Delhi, INDIA
- Study Director: Jayashree Sood, MD,FFRCA, Sir Ganga Ram Hospital, New Delhi, INDIA
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
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
Other Study ID Numbers
- EC/01/17/1105
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.
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