| 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
|
|
|
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
|
|
|
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
|
|
|
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
- What data in particular will be shared?
Response (Others) -
- 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
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [apsin@hotmail.com].
- 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.
- 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. |