A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Subjects included in this study must be:
- •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
Arms & Interventions
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.
Intervention: Aprepitant (Drug)
80 mg of placebo
. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia.
Intervention: Aprepitant placebo (Drug)
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported