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Opioid-based Versus Opioid-free Anaesthesia for Laparoscopic Cholecystectomy

NCT06476600 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2025-02-04

No results posted yet for this study

Summary

This is a prospective, randomized, parallel-group, double-blinded clinical trial. The study is approved by the DUHS institutional review board (IRB) and the trial will be registered at clinical trial registry. The participants of the study will be invited once they receive full trial information from the surgeons or the anesthetists during their pre-assessment visits. The study participants will join only for up to one day after the surgery (Post-operative day-1). The intervention consists of administration of dexmedetomidine infusion in opioid free anesthesia (OFA) group versus Nalbuphine IV bolus in opioid-based anesthesia (OA) group, five minutes before induction of anesthesia. For maintenance in OFA group dexmedetomidine infusion is to be continued whereas in OA group Nalbuphine IV bolus doses will be administered. Once the surgery is completed and after extubation and emergence from anesthesia, all the participants will be transferred to PACU from where they will be in turn discharged to the ward once they will fulfil the recovery discharge criteria. A multi-modal analgesia regimen along with a prophylactic antiemetic medication will be prescribed postoperatively to all the patients in the ward according to the standard protocol of the department.

Conditions

  • Surgical Procedure, Unspecified
  • Laparoscopic Cholecystectomy

Interventions

DRUG

Dexmedetomidine injection

All the eligible patients will undergo general anaesthesia for their elective surgeries (Laparoscopic Cholecystectomies). For the induction and maintenance of anaesthesia the participants will be randomised in a 1:1 ratio to receive either a standard opioid-based anaesthesia (by Nalbuphine) or opioid-free anaesthesia (by Dexmedetomidine) treatment protocols.

DRUG

Nalbuphine Injection

All the eligible patients will undergo general anaesthesia for their elective surgeries (Laparoscopic Cholecystectomies). For the induction and maintenance of anaesthesia the participants will be randomised in a 1:1 ratio to receive either a standard opioid-based anaesthesia (by Nalbuphine) or opioid-free anaesthesia (by Dexmedetomidine) treatment protocols.

Sponsors & Collaborators

  • Atif Shafqat

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-10-15
Completion
2024-10-31

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06476600 on ClinicalTrials.gov