Baclofen in Preventing Postoperative Nausea and Vomiting After Bariatric Surgery

Study Overview
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Brief Summary
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This study aims to evaluate the possible efficacy of baclofen on postoperative nausea and vomiting in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.

Detailed Description
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. A total of 100 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 four groups by closed envelop method

Official Title
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Clinical Study Evaluating the Efficacy of Baclofen in Preventing Postoperative Nausea and Vomiting After Laparoscopic Sleeve Gastrectomy

Conditions
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Postoperative Nausea and Vomiting, Laparoscopic Sleeve Gastrectomy, Morbid Obesity

Intervention / Treatment
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* Drug: Baclofen Tablets


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 |
| --- | --- |
| No Intervention: Group 1(Control group)<br>include 50 patients scheduled for sleeve gastrectomy | |
| Experimental: Group 2<br>which include 50 patients scheduled for sleeve gastrectomy | Drug: Baclofen Tablets<br>* 10 mg oral baclofen 1 h before anesthesia<br>* Other names: baclofen;|

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 | 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 serum level of vasopressin | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | The first 48 hours after surgery. | 
| Change in serum level of substance P | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | The first 48 hours after surgery. | 
| Change in serum level of dopamine | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | The first 48 hours after surgery. | 
| Change in serum level of serotonin | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | The first 48 hours after surgery. | 
| Change in serum level of tachykinin 1 | Blood samples will be collected at baseline, 24 hours and 48 hours after surgery | 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, baclofen, Morbid Obesity