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

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.

Study Overview

• Status: Completed
• Conditions: Postoperative Nausea and Vomiting
• Intervention / Treatment: Other: Dual therapy; Other: General anesthesia; Other: Monotherapy

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 Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Lebanon
  • Beirut, Lebanon
    • Makassed General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / 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: General anesthesia; Induction of general anesthesia will be performed followed by endotracheal intubation.; Other: Monotherapy; 10 mg metoclopramide

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Makassed General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 15, 2018
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: March 3, 2018
• First Submitted That Met QC Criteria: March 3, 2018
• First Posted (Actual): March 8, 2018

Study Record Updates

• Last Update Posted (Actual): September 27, 2019
• Last Update Submitted That Met QC Criteria: September 26, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Signs and Symptoms, Digestive; Nausea; Vomiting; Postoperative Nausea and Vomiting; Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics
• Other Study ID Numbers: 122018

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No