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

University of Pennsylvania

Status

Completed

Conditions

Vomiting

Nausea

Treatments

Drug: Aprepitant

Drug: Aprepitant placebo

Study type

Interventional

Funder types

Other

Identifiers

NCT00956215

Emend

Details and patient eligibility

About

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.

Full 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.

Enrollment

125 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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