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

Time-to-first-rescue Antiemetic With Ondansetron Plus Metoclopramide Versus Dexamethasone Plus Metoclopramide for PONV Prophylaxis in Laparoscopic Cholecystectomy: a Randomized, Triple-Blind, Superiority Trial

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

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