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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Postoperative Nausea and Vomiting

Intervention / Treatment
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* Other: Dual therapy
* Other: Monotherapy
* Other: General anesthesia


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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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 |