---
title: Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery
nct_id: NCT03459248
overall_status: COMPLETED
phase: NA
sponsor: Makassed General Hospital
study_type: INTERVENTIONAL
primary_condition: Postoperative Nausea and Vomiting
countries: Lebanon
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT03459248.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT03459248"
ct_last_update_post_date: 2019-09-27
last_seen_at: "2026-05-12T06:44:34.984Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery

**Official Title:** Metoclopramide-Ondansetron Dual Therapy vs Metoclopramide Monotherapy for Treatment of Nausea and Vomiting Post Laparoscopic Cholecystectomy

**NCT ID:** [NCT03459248](https://clinicaltrials.gov/study/NCT03459248)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 120
- **Lead Sponsor:** Makassed General Hospital
- **Conditions:** Postoperative Nausea and Vomiting
- **Start Date:** 2018-02-15
- **Completion Date:** 2019-07-31
- **CT.gov Last Update:** 2019-09-27

## Brief Summary

The incidence of postoperative nausea and vomiting (PONV) after general anesthesia is up to 30% when inhalational anesthetics are used with no prophylaxis. This makes PONV one of the most common complaints following surgery under general anesthesia, together with postoperative pain.

## Detailed Description

This is a prospective, randomized, double-blind controlled clinical trial. Written informed consent will be obtained from patients. Patients will be randomly assigned using the sealed envelope technique into 2 equal groups:

Group 1: Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia.

Group 2: Patients will receive 10 mg metoclopramide before induction of general anesthesia.

## Eligibility

- **Minimum age:** 16 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Patients aging 16 years and above
* Patients undergoing laparoscopic cholecystectomy under General Anesthesia at Makassed General Hospital

Exclusion Criteria:

* Patients with history of motion sickness
* Patients on previous treatment by anti-emetics for dizziness, vertigo or other causes of nausea and vomiting
* Patients with any type of allergy to metoclopramide or ondansetron
* Patients refusing to be part of the study (refusal to sign consent)
* Patients on previous treatment by opioids
```

## Arms

- **Dual therapy** (EXPERIMENTAL) — Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia
- **Monotherapy** (ACTIVE_COMPARATOR) — Patients will receive 10 mg metoclopramide before induction of general anesthesia.

## Interventions

- **Dual therapy** (OTHER) — combination of 10 mg metoclopramide with 4 mg ondansetron
- **Monotherapy** (OTHER) — 10 mg metoclopramide
- **General anesthesia** (OTHER) — Induction of general anesthesia will be performed followed by endotracheal intubation.

## Primary Outcomes

- **postoperative nausea and vomiting** _(time frame: 36 hours postoperatively)_ — The Primary aim of this study is to compare the effect of prophylactic combination therapy (dual therapy) metoclopramide-ondansetron vs. ondansetron monotherapy for the treatment of postoperative nausea and vomiting after laparoscopic cholecystectomy. This will be assessed through a questionnaire with yes or no question where yes indicates the presence of nausea or vomiting and no indicating the absence of nausea or vomiting.

## Secondary Outcomes

- **Surgeon satisfaction** _(time frame: 36 hours postoperatively)_
- **Patient satisfaction** _(time frame: 36 hours postoperatively)_

## Locations (1)

- Makassed General Hospital, Beirut, Lebanon

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `locations.makassed general hospital|beirut||lebanon` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT03459248.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT03459248*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*