Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Study Overview
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Brief Summary
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The aim of this study is to compare the possible efficacy of ondansetron and gabapentin on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

Detailed Description
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This study will be a double blind randomized, controlled, parallel, study. A total of1 00 morbidly obese patients who will be scheduled for sleeve gastrectomy will be included in the study. The patients will be selected from those attending Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt. The participants will be randomized into two groups by closed envelop method,

Official Title
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Comparative Clinical Study Among Ondansetron and Gabapentin in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Conditions
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Post Operative Nausea and Vomiting, Sleeve Gastrectomy, Morbid Obesity

Intervention / Treatment
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* Drug: Ondansetron 8mg
* Drug: Gabapentin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both male and female patients will be included. Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes. Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity. Patients fit for anesthesia and surgery. Exclusion Criteria: - Patients with BMI >55 kg/m2. Patients with previous procedures for the treatment of obesity. Pregnant females and lactating women. Patients with psychological or psychiatric disease Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery Patients who experienced vomiting within 24 hours before surgery. Patients with history of alcohol or drug abuse. Patients with hypersensitivity or contraindications to any of the drugs used in this study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1<br>include 50 patients scheduled for sleeve gastrectomy | Drug: Ondansetron 8mg<br>* 50 patients will receive intravenous ondansetron 8 mg before the end of surgery.<br>* Other names: zofran;|
| Experimental: Group 2<br>include 50 patients scheduled for sleeve gastrectomy | Drug: Gabapentin<br>* 50 patients will receive 600 mg oral gabapentin 1 h before anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome of this study will be the complete response within the first 48 h after surgery. | Complete response is defined as the absence of PONV and the lack of a need for rescue antiemetic therapy | The first 48 hours after surgery. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the level of the biological parameter vasopressin | 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of vasopressin | The first 48 hours after surgery. | 
| change in the level of the biological parameter dopamine | 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of dopamine | The first 48 hours after surgery. | 
| change in the level of the biological parameter substance p | 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of substance p | The first 48 hours after surgery. | 
| change in the level of the biological parameter Serotonin | 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Serotonin | The first 48 hours after surgery. | 
| change in the level of the biological parameter Tachykinin 1 | 5 ml of venous blood will be withdrawn from each participant by antecubital venipuncture. Blood samples will be centrifuged at 3000 rpm for 15 min to separate sera. Sera will be kept at deep freeze (-80°C) until analysis of serum concentrations of Tachykinin 1 | The first 48 hours after surgery. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, ondansetron, gabapentine