Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients (PONV)
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|ClinicalTrials.gov Identifier: NCT00956215|
Recruitment Status : Completed
First Posted : August 11, 2009
Last Update Posted : February 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Nausea Vomiting||Drug: Aprepitant Drug: Aprepitant placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||125 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients|
|Study Start Date :||May 2010|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||January 2012|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956215
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Ashish Sinha, MD||University of Pennsylvania|