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CTRI Number  CTRI/2024/01/061321 [Registered on: 10/01/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Anesthesia with no opioids will improve safety in patients with extreme obesity: a double blind randomised controlled study. 
Scientific Title of Study   Opioid free technique enhances safety in patients with morbid obesity and obstructive sleep apnea, undergoing non -bariatric surgery : a double blind randomised controlled study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Aparna Sinha 
Designation  Senior Director  
Affiliation  Max Healthcare 
Address  Max Super Speciality Hospital East wing 2 Press enclave, Road Saket, New Delhi, 110,017
Max Super Speciality Hospital East wing 2 Press enclave, Road Saket, New Delhi, 110,017
South
DELHI
110017
India 
Phone  9810035503  
Fax    
Email  aparna.sinha@maxhealthcare.com  
 
Details of Contact Person
Scientific Query
 
Name  Aparna Sinha 
Designation  Senior Director  
Affiliation  Max Healthcare 
Address  Max Super Speciality Hospital East wing 2 Press enclave, Road Saket, New Delhi, 110,017
Max Super Speciality Hospital East wing 2 Press enclave, Road Saket, New Delhi, 110,017
South
DELHI
110017
India 
Phone  9810035503  
Fax    
Email  aparna.sinha@maxhealthcare.com  
 
Details of Contact Person
Public Query
 
Name  Aparna Sinha 
Designation  Senior Director  
Affiliation  Max Healthcare 
Address  Max Super Speciality Hospital East wing 2 Press enclave, Road Saket, New Delhi, 110,017
Max Super Speciality Hospital East wing 2 Press enclave, Road Saket, New Delhi, 110,017
South
DELHI
110017
India 
Phone  9810035503  
Fax    
Email  aparna.sinha@maxhealthcare.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Max Healthcare 
Address  2 Press enclave, Road, East wing, Saket New Delhi 110017 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Aparna Sinha   Max Super Speciality Hospital  Second floor, MAMBS OT Complex 2 Press enclave Road, East wing, Saket New Delhi 110017
South
DELHI 
9810035503

apsin@hotmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IECDDF  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E889||Metabolic disorder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional pain management using Opioids (Fentanyl)  Multimodal analgesia using opioids with Paracetamol and NSAIDS but no regional technique 
Intervention  Opioid-free anaesthesia (OFA)  Opioid-free anaesthesia with loco-regional blocks and other non opioid medications including NSAIDS, Paracetamol and Ketamine 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Eligible patients will include consented adult patients of either gender, between the age of 18 and 65; body mass index (BMI) between 40 and 60; planned for elective laparoscopic cholecystectomy under general anesthesia 
 
ExclusionCriteria 
Details  Patients with preoperative chronic use of opioid or NSAID; allergy to bupivacaine; local skin infection at the injection site of USTAP (ultrasound guided subcostal transverse abdominis plane block); liver or renal insufficiency; psychiatric, or neurological disease; prior open abdominal surgery above T10 dermatome; patients converted to open surgery; and patients expected to be subjected to more tissue trauma will be excluded from the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Discharge readiness : DR in hours  Discharge readiness : DR in hours 
 
Secondary Outcome  
Outcome  TimePoints 
Assessment of OFA on discharge readiness, quality of recovery, opioid consumption and patient satisfaction  At the time of discharge readiness 
 
Target Sample Size   Total Sample Size="139"
Sample Size from India="139" 
Final Enrollment numbers achieved (Total)= "224"
Final Enrollment numbers achieved (India)="224" 
Phase of Trial   N/A 
Date of First Enrollment (India)   15/01/2024 
Date of Study Completion (India) 30/05/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response (Others) - 

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [apsin@hotmail.com].

  6. For how long will this data be available start date provided 01-01-2025 and end date provided 31-12-2029?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Opioids have been known to potentiate airway related adverse events related to sleep-disordered breathing in all patients, moreso, in the patients with morbid obesity. There is progressively large number of surgical patients with obesity and obstructive sleep apnea requiring not just bariatric but also non-bariatric surgery. 

There are increasing reports of post operative adverse events in them.particularly  high risk of airway related adverse events (ARAE: risk of obstructed breathing, increased sedation and hypersomnolence) in the postoperative period. Furthermore, opioids are likely to put hurdle by increasing nausea, vomiting, respiratory depression, delayed emergence with hypoventilation , muscle fatigue , ileus and urinary retention to name a few. [4].

This remains a major deterrent while considering them for general anesthesia or ambulatory surgery. Though laparoscopic surgeries under ERAS (enhanced recovery after surgery) represents the best possible patient safety and quality improvement program, there remains a caveat with respect to use of opioids.  

Anaesthetic considerations in ERAS have been well established including the multimodal analgesic approach, there remains speculation that opioid-free anaesthesia may offer additional benefit to achieve the goals of ERAS moreso, for this vulnerable group of patients. This remains main reason for considering use of opioid-free anesthesia techniques in them..

The concept of OFA (opioid free analgesia) techniques in the era of evidence- based medicine has emerged as a feasible safe option.  There is paucity of well structured studies to support the concept of OFA in this population.

 
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