Metoclopramide-Ondansetron vs. Metoclopramide Therapy for Treatment of Nausea and Vomiting Post Laparoscopic Surgery

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03459248

Enrollment

120

Registered

2018-03-08

Start date

2018-02-15

Completion date

2019-07-31

Last updated

2019-09-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Nausea and Vomiting

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.

Interventions

OTHERDual therapy

combination of 10 mg metoclopramide with 4 mg ondansetron

OTHERMonotherapy

10 mg metoclopramide

OTHERGeneral anesthesia

Induction of general anesthesia will be performed followed by endotracheal intubation.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
postoperative nausea and vomiting	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

Measure	Time frame	Description
Surgeon satisfaction	36 hours postoperatively	Assess surgeon satisfaction with anesthesia using a questionnaire named the Surgeon Satisfaction with Anesthesia Services Scales. The questionnaire uses a scale: 1-strongly disagree, 2- disagree, 3- agree, 4- strongly agree
Patient satisfaction	36 hours postoperatively	Assess patient satisfaction with anesthesia using the Iowa Satisfaction Anesthesia scale which measures patient satisfaction through a scale: strongly disagree, disagree, undecided, agree and strongly agree

Countries

Lebanon

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026