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

Postoperative Nausea and Vomiting Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03459248
• Other study ID #: 122018
• Status: Completed
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2019
• Source: Makassed General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Other:
• Dual therapy
combination of 10 mg metoclopramide with 4 mg ondansetron
• Monotherapy
10 mg metoclopramide
• General anesthesia
Induction of general anesthesia will be performed followed by endotracheal intubation.

Locations

Country	Name	City	State
Lebanon	Makassed General Hospital	Beirut

Sponsors (1)

Lead Sponsor	Collaborator
Makassed General Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	36 hours postoperatively
Secondary	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	36 hours postoperatively
Secondary	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	36 hours postoperatively