| CTRI Number |
CTRI/2025/04/085212 [Registered on: 21/04/2025] Trial Registered Prospectively |
| Last Modified On: |
13/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Two Types of Anaesthesia (with and without Opioids) for patients undergoing keyhole Abdominal Surgeries. |
|
Scientific Title of Study
|
Opioid-free (OFA) versus Opioid-based(OBA) Anaesthesia in Laparoscopic Abdominal Surgeries:A Prospective Randomized Controlled Trial |
| Trial Acronym |
OFA and OBA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Lalit Kumar |
| Designation |
PG student |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral,Delhi Cantt,New Delhi
New Delhi
DELHI
110010
India |
| Phone |
8787021323 |
| Fax |
|
| Email |
dr.lalit.94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Bhavna Hooda |
| Designation |
Professor |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral,Delhi Cantt,New Delhi
New Delhi
DELHI
110010
India |
| Phone |
9910663810 |
| Fax |
|
| Email |
drbhavnahooda@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhavna Hooda |
| Designation |
Professor |
| Affiliation |
Army Hospital Research and Referral |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral,Delhi Cantt,New Delhi
New Delhi
DELHI
110010
India |
| Phone |
9910663810 |
| Fax |
|
| Email |
drbhavnahooda@gmail.com |
|
|
Source of Monetary or Material Support
|
| Army Hospital Research and Referral, New Delhi |
|
|
Primary Sponsor
|
| Name |
Bhavna Hooda |
| Address |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral,Delhi Cantt,New Delhi |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Gaurav Purohit |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral,Delhi Cantt,New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Bhavna Hooda |
Army Hospital Research and Referral |
Department of Anaesthesiology and Critical Care, Army Hospital Research and Referral,Delhi Cantt,New Delhi
New Delhi
DELHI |
9910663810
drbhavnahooda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Opioid Based Anaesthesia(OBA) |
Control Group (Standard Opioid-Based Anaesthesia):
Induction done with-
Fentanyl: 1–2 µg/kg
Propofol: 1.5–2.5 mg/kg
Atracurium 0.5mg/kg
Maintenance:
Anaesthesia will be maintained by Sevoflurane in Air and oxygen mixture to maintain anaesthesia depth and boluses of Atracurium for muscle relaxation.
Additional fentanyl boluses as required. (increase in HR or MAP more than 10% of baseline).
|
| Intervention |
Opioid Free Anaesthesia(OFA) |
Induction done with-
Dexmedetomidine: Loading dose of 0.6 µg/kg over 10 minutes, followed by a maintenance infusion of 0.5 µg/kg/h.
Ketamine: Bolus of 0.5 mg/kg at induction.
Propofol: 1.5-2.5 mg/kg
Atracurium 0.5mg/kg
Maintenance:
Additional ketamine boluses of 0.25 mg/kg will be administered as needed. (on the basis of increase in HR or MAP more than 10% of baseline)
Anaesthesia will be maintained by Sevoflurane in Air and oxygen mixture to maintain anaesthesia depth.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult aged 18 years and older undergoing laparoscopic abdominal surgeries. 2. ASA classification I-II .3. Patients capable of providing informed consent or with consent provided by legal guardian |
|
| ExclusionCriteria |
| Details |
1.Patients with contraindications or allergies to study medications.
2.Patients with chronic opioid use or opioid dependence.
3. Pregnant or lactating women.
4.Patients refusal. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare postoperative pain scores in both groups by using Numeric Rating Scale(NRS). |
At immediate postop, 06 hours,12 hours,24 hours postoperatively. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine analgesic requirement within first 24 hours.
Time to first analgesic request
Incidence of postoperative nausea and vomiting
Sedation scores(RASS Scale) and patient satisfaction. |
At 06 hours , 12hours , 24 hours postoperatively. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
24/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- 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 (Others) -
- For how long will this data be available start date provided 21-04-2025 and end date provided 10-04-2028?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Anaesthesia is built upon four pillars that ensure a safe and effective perioperative experience. The four pillars being hypnosis, autonomic stability ,muscle relaxation and analgesia. Opioids have long been the primary choice for managing perioperative pain due to their strong analgesic effects. However, their use is fraught with significant adverse effects such as respiratory depression ,post-operative nausea ,vomiting, ileus and the risk of dependence or addiction. Apart from this ,the opioid epidemic is a global public health crisis characterized by the widespread misuse of opioid medications ,leading to addiction ,overdose and death. The over-reliance on opioids for pain management , particularly in perioperative care ,has contributed to this crisis, necessitating alternative approaches. Opioid free anaesthesia (OFA) aims to achieve analgesia without the use of opioids ,instead utilizing a multimodal analgesic regimen with non opioid analgesics, regional anaesthesia techniques,and adjunctive pharmacologic agents .Moreover, OFA has been increasingly integrated into Enhanced recovery after surgery (ERAS) protocols, promoting faster recovery, reduced opioid related complications and improved postoperative outcomes. Given the ongoing opioid epidemic and the rising awareness of opioid related morbidity and mortality, there is an urgent need to re evaluate perioperative opioid use and explore opioid sparing straregies that maintain effective analgesia while enhancing recovery. This prospective, randomized controlled trial aims to compare the efficacy of OFA versus traditional opioid based anaesthesia(OBA) in patients undergoing laparoscopic abdominal surgeries. |