The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting

Study Overview
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Brief Summary
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The purpose of this study is to assess the efficacy of Aprepitant + standard antiemetic regimen in reducing postoperative nausea and vomiting after laparoscopic gastric sleeve versus placebo + standard antiemetic regimen

Detailed Description
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After being informed about the study, all patients who provide written informed consent and meet the eligibility requirements will be randomized in a triple-blind manner (participant, evaluator, and investigator) in a 1:1 ratio to Aprepitant (80 or 125 mg) + standard antiemetic regimen (once two hours before surgery) or placebo + standard antiemetic regimen(once two hours before surgery). The standard antiemetic regimen will be Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg

Official Title
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The Effect of Aprepitant Reducing Postoperative Nausea and Vomiting in Patients Undergoing Laparoscopic Gastric Sleeve Surgery

Conditions
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Obesity, Nausea and Vomiting, Postoperative

Intervention / Treatment
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* Drug: Aprepitant
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 to 65 years old. Non-smokers. Obesity with BMI > 30 kg/m2. Undergoing laparoscopic gastric sleeve. Exclusion Criteria: Documented hypersensitivity to any component of the study regimen. Current treatment with: Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole) or Propulsid (cisapride). Allergy to opioid drugs used in the anesthetic protocol. Drug or alcohol abuse. Chronic nausea and vomiting. Previous bariatric procedures.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: A randomized controlled clinical trial conducted in obese patients undergoing laparoscopic gastric sleeve surgery to assess the efficacy of Aprepitant (80 or 125 mg) in combination with a standard antiemetic regimen (Ondansetron + Metoclopramide + Dexamethasone) is presented vs placebo + the same standard regimen, evaluating postoperative nausea and vomiting by means of a specific scale (Rhodes index) for the assessment of nausea and vomiting
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Aprepitant<br>Aprepitant (80 or 125 mg) + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg | Drug: Aprepitant<br>* 80 or 125 mg tablet + standard antiemetic regimen, once two hours before surgery<br>|
| Placebo Comparator: Placebo<br>Placebo + Ondansetron 8 mg + Metoclopramide 10 mg + Dexamethasone 8 mg | Other: Placebo<br>* Placebo + standard antiemetic regimen, once two hours before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient's postoperative nausea and vomiting evaluation at 0 hrs (Rhodes index) | Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhodes scale | 0 postoperative hours | 
| Patient's postoperative nausea and vomiting evaluation at 6 hrs (Rhodes index) | Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale | 6 postoperative hours | 
| Patient's postoperative nausea and vomiting evaluation at 12 hrs (Rhodes index) | Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale | 12 postoperative hours | 
| Patient's postoperative nausea and vomiting evaluation at 24 hrs (Rhodes index) | Change of postoperative nausea and vomiting after laparoscopic gastric sleeve using Rhoades scale | 24 postoperative hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic Gastric Sleeve, Bariatric Surgery, Nausea and Vomiting, Postoperative, Aprepitant