| CTRI Number |
CTRI/2026/03/105681 [Registered on: 09/03/2026] Trial Registered Prospectively |
| Last Modified On: |
09/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study Comparing Opioid-Free Anesthesia Using Ketamine and Dexamethasone with Conventional Opioid-Based Anesthesia in Women Undergoing Laparoscopic Tubal Ligation. |
|
Scientific Title of Study
|
A Randomized Controlled Trial Comparing Opioid Free Protocol Using Combination of intravenous Ketamine Dexamethasone and Conventional opioid-based Regime for Laproscopic Tubal Ligation |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dipakshi Phooli |
| Designation |
DNB Student |
| Affiliation |
Dr Baba saheb ambedkar hospital and medical college |
| Address |
Main Operation Theater,2nd floor, Department of Anaesthesia, Dr. Baba Saheb Ambedkar Medical College and Hospital, sector-6, Rohini, Deilhi
North West
DELHI
110085
India |
| Phone |
9810013661 |
| Fax |
|
| Email |
Phooli.3595@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nandita Joshi |
| Designation |
Associate Proffesor |
| Affiliation |
Dr Baba saheb ambedkar hospital and medical college |
| Address |
Main Operation Theater,2nd floor, Department of Anaesthesia, Dr. Baba Saheb Ambedkar Medical College and Hospital, sector-6, Rohini, Deilhi
North West
DELHI
110085
India |
| Phone |
9811927328 |
| Fax |
|
| Email |
nandita2511@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dipakshi Phooli |
| Designation |
DNB Student |
| Affiliation |
Dr. Baba Saheb Ambedkar Medical college and Hospital |
| Address |
Main Operation Theater,2nd floor, Department of Anaesthesia, Dr. Baba Saheb Ambedkar Medical College and Hospital, sector-6, Rohini, Deilhi
North West
DELHI
110085
India |
| Phone |
9810013661 |
| Fax |
|
| Email |
Phooli.3595@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Baba Saheb Ambedkar Medical College and Hospital |
| Address |
Main Operation Theater,2nd floor, Department of Anaesthesia, Dr. Baba Saheb Ambedkar Medical College and Hospital, sector-6, Rohini, Delhi 110085 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| Dr Dipakshi Phooli |
Dr Baba Saheb Ambedkar Medical College and Hospital |
Main Operation Theater, 2nd Floor, Department of Anaesthesia
North West
DELHI |
9810013661
phooli.3595@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Baba Saheb Ambedkar Medical College and Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
fentanyl |
propofol (2 mg/kg) + fentanyl (2 mcg/kg) + normal saline (2 ml) at inductionwithin 30 mins |
| Intervention |
ketamine and dexamethasone |
propofol (2 mg/kg) + ketamine (0.5 mg/kg) + dexamethasone (8 mg) at induction within 30 mins |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
merican Society of Anesthesiologists (ASA) Physical Status I or II.
Scheduled for elective laparoscopic tubal ligation under procedural sedation and analgesia.
Willing to participate and provide written informed consent. |
|
| ExclusionCriteria |
| Details |
Body Mass Index (BMI) more than 30 kg/meter square.
Known allergy or hypersensitivity to propofol, ketamine, dexamethasone, fentanyl, or any study drug.
History of diabetes mellitus.
Presence of acute or chronic infection.
History of chronic opioid use.
History of substance abuse.
History of psychiatric illness.
History of gastroesophageal reflux disease (acid reflux).
History of any pulmonary disease (e.g., asthma, COPD). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time to first rescue analgesic
Intraoperative haemodynamic parameters.
Additional intraoperative propofol requirement. |
4 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Postoperative pain (VAS score up to 6 hours).
Incidence of PONV & antiemetic requirement.
Duration of PACU stay (time to PADSS more than equal to 9).
Patient satisfaction score.
Failure of OFA.
Adverse events |
4 hours |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 3 |
|
Date of First Enrollment (India)
|
23/03/2026 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Laparoscopic tubal ligation is commonly performed under procedural sedation and analgesia using opioid-based regimens. Opioids, although effective, are associated with adverse effects such as respiratory depression, postoperative nausea and vomiting, delayed recovery, and risk of persistent opioid use. Opioid-free anaesthesia (OFA) has emerged as an alternative strategy to reduce opioid-related complications. This randomized, double-blind controlled trial aims to compare the efficacy and safety of an opioid-free protocol using intravenous ketamine and dexamethasone in combination with propofol versus a conventional opioid-based regimen using fentanyl and propofol in women undergoing laparoscopic tubal ligation. A total of 100 ASA I–II female patients aged 18–45 years will be randomized into two equal groups. The primary outcomes include postoperative analgesic requirement, intraoperative haemodynamic stability, and additional propofol requirement. Secondary outcomes include postoperative pain scores, postoperative nausea and vomiting, duration of PACU stay, patient satisfaction, failure of opioid-free anaesthesia, and adverse events. The study aims to evaluate whether the ketamine–dexamethasone combination provides effective analgesia with fewer opioid-related side effects and improved recovery characteristics. |