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Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy

NCT07638527 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-09-04

No results posted yet for this study

Summary

The goal of this superiority randomized controlled trial (RCT) is to learn if one dual-drug arm increases patient comfort (time to needing rescue medication for nausea/vomiting) more effectively than the other in adults with Moderate-to-High PONV risk (Apfel score 2-4) undergoing elective laparoscopic cholecystectomy (gallbladder surgery).

The main question this study aims to answer is:

• Does Ondansetron plus Metoclopramide prolong time to first rescue antiemetic more than Dexamethasone plus Metoclopramide?

Researchers will compare Group A (Ondansetron 4mg plus Metoclopramide 10mg IV) to Group B (Dexamethasone 8mg IV plus Metoclopramide 10mg IV) to see if Group A provides a longer time to first rescue medication.

Participants will:

* Receive their assigned, blinded drug group 5-10 minutes before general anesthesia induction.
* Receive rescue Metoclopramide 10mg IV if they experience any vomiting or severe nausea
* Be monitored for 24 hours post-surgery in the hospital
* Report nausea severity at 2, 6, 12 and 24 hours post-surgery

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

ondansetron 4 mg

Ondansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.

DRUG

Dexamethasone (intravenous)

Dexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.

DRUG

Metoclopramide 10mg

Metoclopramide 10 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia as part of dual-agent PONV prophylaxis. Also used as rescue antiemetic (10 mg IV) if patient has vomiting or VRS \>4 for nausea.

Sponsors & Collaborators

  • Faisalabad Medical University

    lead OTHER

Principal Investigators

  • Asifa Saeed, MBBS; FCPS · Faisalabad Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-30
Primary Completion
2027-03-31
Completion
2027-04-30

Countries

  • Pakistan

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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 NCT07638527 on ClinicalTrials.gov