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

Not Applicable

Completed

• Conditions: Vomiting; Nausea
• Interventions: Drug: Aprepitant placebo; Drug: Aprepitant

• Registration Number: NCT00956215
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2009-08-10
• Study First Submitted QC: 2009-08-10
• Study First Posted: 2009-08-11
• Study Start: 2010-05
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-14
• Last Update Posted: 2012-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
80 mg of placebo	Aprepitant placebo	. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia.
80mg of Aprepitant	Aprepitant	Patients will be randomized to receive 80mg of Aprepitant with 50 ml of water no later than 30 minutes before induction of anesthesia.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States