Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients

Study Overview
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Brief Summary
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The study drug, Aprepitant, is currently used to control chemotherapy induced nausea and vomiting and is also approved for post-operative nausea and vomiting. The investigators' evaluation of it in morbidly obese patients will demonstrate its ability to control nausea and vomiting post-operatively in this subset of patients.

Detailed Description
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The purpose of this study is to evaluate the effectiveness of Aprepitant, also known as Emend, in reducing post-operative nausea and vomiting in morbidly obese patients. Post-operative nausea and vomiting that occurs in morbidly obese patients can greatly increase the chances of complications during the post-operative period. By treating morbidly obese patients with Aprepitant, the goal is to reduce the risk of such complications that may be induced by nausea and vomiting.

Official Title
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A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Aprepitant
* Drug: Aprepitant placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects included in this study must be: Female At least 18 years of age Non-smoking At high risk for PONV Obese with a BMI of at least 45 kg/m2 Undergoing upper gastrointestinal surgery requiring postoperative opioid analgesia Exclusion Criteria: Subjects will be excluded if: They have a known allergy to Aprepitant or Ondansetron They are currently taking Orap (pimozide), Seldane (terfenadine), Hismanal (astemizole), or Propulsid (cisapride) They are pregnant They are breastfeeding They plan on getting pregnant in the 2 months following surgery They are not able to receive patient controlled analgesia (PCA) following surgery They have a known drug or alcohol abuse problem They have chronic nausea and vomiting

Ages Eligible for Study
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Minimum Age: 18 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
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 80mg of Aprepitant<br>Patients will be randomized to receive 80mg of Aprepitant with 50 ml of water no later than 30 minutes before induction of anesthesia. | Drug: Aprepitant<br>* 80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery<br>|
| Placebo Comparator: 80 mg of placebo<br>. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia. | Drug: Aprepitant placebo<br>* 80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the efficacy of 80mg Aprepitant in preventing post operative nausea or vomiting in morbidly obese patients (BMI of 45 kg/m2 or higher) undergoing upper gastrointestinal surgery. |  | 72 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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post operative, obese