Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Me… (NCT07638527) | Clinical Trial Compass
Not Yet RecruitingPhase 4
Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy
Pakistan264 participantsStarted 2026-07
Plain-language 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
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Time to First Rescue Antiemetic (in minutes)
Timeframe: First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)