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

Makassed General Hospital120 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

TRIPLE

Enrollment

120

Conditions

Postoperative Nausea and Vomiting

Interventions

Dual therapyOTHER

combination of 10 mg metoclopramide with 4 mg ondansetron

MonotherapyOTHER

10 mg metoclopramide

General anesthesiaOTHER

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

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (1)

Makassed General Hospital

Beirut, Lebanon

Outcomes

Primary Outcomes

postoperative nausea and vomiting

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.

Time frame: 36 hours postoperatively

Secondary Outcomes

Surgeon satisfaction

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

Time frame: 36 hours postoperatively

Patient satisfaction

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

Time frame: 36 hours postoperatively

Data from ClinicalTrials.gov

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