Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
|Official Title:||A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients|
- 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. [ Time Frame: 72 hours ] [ Designated as safety issue: No ]
|Study Start Date:||May 2010|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
Active Comparator: 80mg of Aprepitant
Patients will be randomized to receive 80mg of Aprepitant with 50 ml of water no later than 30 minutes before induction of anesthesia.
80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery
Placebo Comparator: 80 mg of placebo
. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia.
Drug: Aprepitant placebo
80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956215
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ashish Sinha, MD||University of Pennsylvania|