Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy
Starting soon · Phase 4
Conditions studied: Postoperative Nausea and Vomiting
In brief
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
Key facts
- Study ID
- NCT07638527
- Run by
- Faisalabad Medical University
- People needed
- 264
- Starts
- 2026-07-01
- Expected to finish
- 2027-04-01
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years
- American Society of Anesthesiologists (ASA) physical status I or II
- Scheduled for elective laparoscopic cholecystectomy
- Apfel score 2-4 (moderate to high risk for PONV)
- Provides written informed consent prior to enrollment
You may not qualify if…
- Known allergy or hypersensitivity to ondansetron, dexamethasone, or metoclopramide
- Emergency surgery (e.g., acute cholecystitis, perforation, or gangrene)
- Pregnancy or breastfeeding
- ASA physical status III or IV
- Preexisting hepatic impairment
- Baseline corrected QT (QTc) interval > 420 ms on pre-operative ECG
- History of dystonic reaction to metoclopramide or other dopamine antagonists
- Preexisting renal impairment (e.g., serum creatinine > 1.5 mg/dL or on dialysis)
- Unable or unwilling to provide informed consent
Where it is running
- Faisalabad Medical University — Faisalābad, Punjab Province, Pakistan
Full record on ClinicalTrials.gov
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