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

Not Applicable

Completed

• Conditions: Postoperative Nausea and Vomiting
• Interventions: Other: Monotherapy; Other: Dual therapy; Other: General anesthesia

• Registration Number: NCT03459248
• Lead Sponsor: Makassed General Hospital

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.

Study Timeline

• Study Start: 2018-02-15
• Study First Submitted: 2018-03-03
• Study First Submitted QC: 2018-03-03
• Study First Posted: 2018-03-08
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Status Verified: 2019-09
• Last Update Submitted: 2019-09-26
• Last Update Posted: 2019-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Monotherapy	Monotherapy	Patients will receive 10 mg metoclopramide before induction of general anesthesia.
Monotherapy	General anesthesia	Patients will receive 10 mg metoclopramide before induction of general anesthesia.
Dual therapy	General anesthesia	Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia
Dual therapy	Dual therapy	Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Makassed General Hospital; 🇱🇧 Beirut, Lebanon