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A Study Comparing Opioid-Free Anesthesia Using Ketamine and Dexamethasone with Conventional Opioid-Based Anesthesia in Women Undergoing Laparoscopic Tubal Ligation.

A Randomized Controlled Trial Comparing Opioid Free Protocol Using Combination of intravenous Ketamine Dexamethasone and Conventional opioid-based Regime for Laproscopic Tubal Ligation - NIL

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/105681
Enrollment
100
Registered
2026-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: O- Medical and Surgical

Interventions

Intervention1: ketamine and dexamethasone: propofol (2 mg/kg) + ketamine (0.5 mg/kg) + dexamethasone (8 mg) at induction within 30 mins Control Intervention1: fentanyl: propofol (2 mg/kg) + fentanyl (

Sponsors

Dr Baba Saheb Ambedkar Medical College and Hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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).

Design outcomes

Primary

MeasureTime frame
Time to first rescue analgesic Intraoperative haemodynamic parameters. Additional intraoperative propofol requirement.Timepoint: 4 hours

Secondary

MeasureTime frame
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 eventsTimepoint: 4 hours

Countries

India

Contacts

Public ContactDr Dipakshi Phooli

Dr Baba saheb ambedkar hospital and medical college

nandita2511@gmail.com9811927328

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026