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

Phase 4RecruitingNCT07638527

Faisalabad Medical University264 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

264

Conditions

Postoperative Nausea and Vomiting

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

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).

Time frame: First 24 hours after surgery (measured from the time of arrival to Post-anaesthesia care unit, PACU)

Secondary Outcomes

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.

Time frame: 24 hours post-surgery

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.

Time frame: Measured at 2, 6, 12, and 24 hours post-surgery

Number of Rescue Doses Required

Total number of rescue antiemetic (metoclopramide 10 mg IV) doses administered to each patient within the first 24 hours.

Time frame: First 24 hours after surgery

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.

Time frame: At hospital discharge (approximately 24 hours post-surgery)