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

Sponsor

Makassed General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03459248

Collaborator

(none)

120

Enrollment

Location

Arms

17.4

Actual Duration (Months)

6.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Nausea and Vomiting	Other: Dual therapy Other: Monotherapy Other: General anesthesia	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Feb 15, 2018

Actual Primary Completion Date :

Jul 31, 2019

Actual Study Completion Date :

Jul 31, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dual therapy Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia	Other: Dual therapy combination of 10 mg metoclopramide with 4 mg ondansetron Other: General anesthesia Induction of general anesthesia will be performed followed by endotracheal intubation.
Active Comparator: Monotherapy Patients will receive 10 mg metoclopramide before induction of general anesthesia.	Other: Monotherapy 10 mg metoclopramide Other: General anesthesia Induction of general anesthesia will be performed followed by endotracheal intubation.

Arm

Intervention/Treatment

Experimental: Dual therapy

Patients will receive 10 mg metoclopramide with 4mg ondansetron before induction of general anesthesia

Other: Dual therapy

combination of 10 mg metoclopramide with 4 mg ondansetron

Other: General anesthesia

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

Active Comparator: Monotherapy

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

Other: Monotherapy

10 mg metoclopramide

Other: General anesthesia

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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Makassed General Hospital	Beirut		Lebanon

Sponsors and Collaborators

Makassed General Hospital

Investigators

Principal Investigator: Zoher Naja, MD, Makassed General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Zoher Naja, Chairperson of Anesthesia and Pain Management Department, Makassed General Hospital

ClinicalTrials.gov Identifier:

NCT03459248

Other Study ID Numbers:

122018

First Posted:

Mar 8, 2018

Last Update Posted:

Sep 27, 2019

Last Verified:

Sep 1, 2019

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nausea

Vomiting

Postoperative Nausea and Vomiting

Anesthetics

Study Results

No Results Posted as of Sep 27, 2019