← Back to all trials
Recruiting
NCT07638527
Time to First Rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy
Conditions: Postoperative Nausea and Vomiting
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 264
Sponsor: Faisalabad Medical University
Location: Faisalabad Medical University Faisalābad Punjab Province
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
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07638527). StuddyBuddy aggregates publicly available trial information.