CTRI

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CTRI Number

CTRI/2025/12/098389 [Registered on: 03/12/2025] Trial Registered Prospectively

Last Modified On:

01/12/2025

Post Graduate Thesis

Yes

Type of Trial

Interventional

Type of Study

Drug
Surgical/Anesthesia

Study Design

Randomized, Parallel Group, Active Controlled Trial

Public Title of Study

Clinical trial to study the effect of two types of drugs Fentanyl and Dexmedetomidine plus ketamine for postoperative pain for patients undergoing laparoscopic cholecystectomy

Scientific Title of Study

A randomized comparative study to evaluate postoperative analgesia between opioid based and opioid free anesthesia in patients undergoing laparoscopic cholecystectomy

Trial Acronym

nil

Secondary IDs if Any

Secondary ID	Identifier
NIL	NIL

Details of Principal Investigator or overall Trial Coordinator (multi-center study)

Name	Sudhir S
Designation	Postgraduate
Affiliation	M S Ramaiah Medical College
Address	Department of Anaesthesiology M S Ramaiah Medical College Bangalore Karnataka 560054 India Bangalore KARNATAKA 560054 India
Phone	9663474161
Fax
Email	drsudhirsherikar1997@gmail.com

Details of Contact Person
Scientific Query

Name	Dr Archana S
Designation	Associate Professor
Affiliation	M S Ramaiah Medical College
Address	Department of Anaesthesiology M S Ramaiah Medical College Bangalore Karnataka 560054 India Bangalore KARNATAKA 560054 India
Phone	9845121444
Fax
Email	archvinddoc@yahoo.co.in

Details of Contact Person
Public Query

Name	Dr Archana S
Designation	Associate Professor
Affiliation	M S Ramaiah Medical College
Address	Department of Anaesthesiology M S Ramaiah Medical College Bangalore Karnataka 560054 India Bangalore KARNATAKA 560054 India
Phone	9845121444
Fax
Email	archvinddoc@yahoo.co.in

Source of Monetary or Material Support

M S Ramaiah Medical College Bangalore, MSRIT Post New BEL Road Bangalore 560054

Primary Sponsor

Name	M S Ramaiah Medical College
Address	MSRIT Post New BEL Road Bangalore 560054
Type of Sponsor	Private medical college

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
Dr Sudhir S	M S Ramaiah Medical College Hospital	Department of Anaesthesiology M S Ramaiah Medical College Bangalore Karnataka 560054 India Bangalore KARNATAKA	9663474161 drsudhirsherikar1997@gmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
M S Ramaiah Medical College Hospital Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: K80\|\|Cholelithiasis,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Nil	Nil
Intervention	opioid based anaesthesia group (OBA)	In opioid based anaesthesia group (OBA) Fentanyl 2 µg/kg will be given and 0.5 µg/Kg Bolus will be given to maintain patient BP within 20% of pre operative measurement.
Comparator Agent	Opioid free anesthesia group (OFA)	Loading dose of dexmedetomidine 0.5mcg/kg over 10 minutes, followed by dexmedetomidine infusion of 0.1 to 0.3mcg/kg/hour will be given to maintain the BP. Injection ketamine 0.5mg/kg was given before incision

Inclusion Criteria

Age From	18.00 Year(s)
Age To	60.00 Year(s)
Gender	Both
Details	1) Patients aged 18 to 60 years 2) American Society of Anaesthesiologists (ASA) classification II or III physical status with BMI of less than 30 kg/m2 3) Patients undergoing Laparoscopic Cholecystectomy

ExclusionCriteria

Details

1. Patients with severe cardiovascular, renal, hepatic disorder
2. Patients with neuropsychiatric disorders
3. Patients with hemodynamic instability
4. Patients with drug allergy
5. Patients with history of malignant hyperthermia and Muscular dystrophy
6. Patients with muscular dystrophy
7. Patients with electrolyte imbalance
8. Patients with History of opioid use 1 month prior to surgery,
9. Patients with chronic opioid addiction

10. Patients with inability to comprehend visual analog scale (VAS)

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

On-site computer system

Blinding/Masking

Open Label

Primary Outcome

Outcome	TimePoints
To compare time to first rescue analgesia between Opiod free Anaesthesia and Opiod based Anaesthesia groups.	Patients will be monitored for postoperative pain and any analgesic requirement 30 minutes after recovery, hourly for 2 hours and every 4 hourly for a period of 24 h.

Secondary Outcome

Outcome	TimePoints
1. To Compare Total Rescue analgesic consumption in first 24hrs. 2. Postoperative pain scores will be assessed using the Visual Analogue Scale (VAS) at specific time intervals—1 hour, 6 hours, 12 hours, & 24 hours post-surgery. 3. Incidence of Post operative Nausea & Vomiting (PONV)	24 hours after surgery
Postoperative pain scores will be assessed using the Visual Analogue Scale (VAS) at specific time intervals—1 hour, 6 hours, 12 hours, & 24 hours post-surgery.	VAS score will be assessed at 1,6,12 & 24 hours after surgery.
Incidence of post operative nausea vomiting	1 hour after surgery

Target Sample Size

Total Sample Size="104"
Sample Size from India="104"
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

N/A

Date of First Enrollment (India)

16/12/2025

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="0"
Months="1"
Days="6"

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 - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.

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 [drsudhirsherikar1997@gmail.com].

For how long will this data be available start date provided 26-12-2027 and end date provided 26-12-2032?
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

Introduction

Laparoscopic cholecystectomy, though minimally invasive, is often associated with significant pain during the immediate post operative period due to peritoneal irritation, pneumoperitoneum, and tissue handling. Opioids remain the standard for peri-operative analgesia but are linked with several adverse effects such as respiratory depression, nausea, constipation, dependence, and delayed recovery.

Opioid free anaesthesia (OFA), which uses multimodal non opioid analgesics (e.g., dexmedetomidine, ketamine), aims to minimize opioid related complications while maintaining adequate analgesia. Evidence suggests OFA may reduce postoperative pain scores, opioid consumption, and PONV.

Need for the Study

Uncontrolled acute postoperative pain increases the risk of developing chronic postoperative pain. Reducing perioperative opioid use is essential to avoid long term opioid dependence and related adverse effects.

Although OFA has been studied, there is limited literature comparing postoperative analgesic outcomes between OFA and opioid based anaesthesia (OBA) specifically in laparoscopic cholecystectomy. This study aims to fill this gap by evaluating postoperative analgesia, rescue analgesic requirements, and PONV incidence.

Hypothesis

Opioid free anaesthesia provides:

Lower rescue analgesic consumption

Lower postoperative VAS pain scores

Earlier PACU discharge

compared to opioid based total intravenous anaesthesia.

Objectives

Primary Objective

To compare the time to first rescue analgesia between OFA and OBA groups.

Secondary Objectives

To compare total rescue analgesic consumption in the first 24 hours.

To evaluate postoperative VAS pain scores at 1, 6, 12, and 24 hours.

To assess the incidence of postoperative nausea and vomiting (PONV).

Methodology

Study Design

Randomised controlled study.

Participants

Patients aged 18 to 60 years undergoing elective laparoscopic cholecystectomy, ASA II or III, BMI less than 30 kg/m².

Exclusion Criteria

Severe systemic diseases, neuropsychiatric disorders, hemodynamic instability, drug allergy, history of opioid use or addiction, malignant hyperthermia, muscular dystrophy, electrolyte imbalance, or inability to comprehend VAS.

Randomisation

104 patients randomized into:

OFA group dexmedetomidine + ketamine

OBA group fentanyl based anaesthesia

Procedure

Standardised general anaesthesia using TCI propofol with BIS monitoring. Postoperative pain assessed via VAS. Tramadol administered if VAS more than or equal to 4.

Outcome Measures

Time to first rescue analgesic

Total 24 hour rescue analgesic dose

VAS scores

PONV incidence

Statistical Analysis

Independent t test for comparing means

Chi-square test for categorical variables

Descriptive statistics for summary values

Expected Results

OFA is expected to prolong time to first rescue analgesia, reduce total opioid requirement, improve postoperative pain scores, and decrease PONV compared to OBA.