Status:
COMPLETED
Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
Lead Sponsor:
University of Pennsylvania
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18+ years
Phase:
NA
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 mo...
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 vomi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00956215
Start Date
May 1 2010
End Date
January 1 2012
Last Update
February 16 2012
Active Locations (1)
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1
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104