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
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)
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
Parallel
ondansetron 4 mg
DrugOndansetron 4 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
Dexamethasone (intravenous)
DrugDexamethasone 8 mg IV administered as a single colorless syringe 5-10 minutes before induction of anesthesia for prevention of postoperative nausea and vomiting.
Metoclopramide 10mg
DrugMetoclopramide 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.
Time to First Rescue Antiemetic (in minutes)
Time in minutes from patient arrival to Post-anaesthesia care unit, PACU (time zero) to administration of rescue metoclopramide 10 mg IV. Rescue is given if patient experiences any episode of vomiting/retching or reports a nausea Verbal Rating Scale (VRS) score \>4. VRS scale is no nausea (0), mild (1-3), moderate (4-6), and severe (7-10).
Incidence of PONV
Proportion of patients experiencing any nausea (VRS \>1) or any vomiting/retching episode within the first 24 hours post-surgery. Verbal Rating Scale (VRS) is a well established measurement scale with a total of 11 points where 0 = no nausea and 10 = worst possible nausea.
Severity of Postoperative Nausea and Vomiting (RINVR Score)
Measured using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). It evaluates 8 dimensions: frequency/duration/distress of nausea; frequency/amount/distress of vomiting; and frequency/distress of retching. Total score range is 0-32, with 0 indicating no nausea, 1-8 mild, 9-16 moderate, 17-24 severe, and 25-32 great nausea. The higher scores indicate worse PONV.
Number of Rescue Doses Required
Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours.
Patient Satisfaction with Antiemetic Treatment
Patient-reported satisfaction measured on a 5-point Likert scale (Very Dissatisfied to Very Satisfied) at the end of hospital stay. Likert scale is a 5-point psychometric survey scale, with 1 indicating very disappointing and 5 indicating very satisfying. The higher the score, the better the treatment was.
Adverse Events
Proportion of patients experiencing any adverse reaction including allergic reaction, headache, perineal burning, dystonia, or QT prolongation on post-operative ECG.
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