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

Nausea Clinical Trial

— PONV  

Official title:

A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00956215
• Other study ID #: Emend
• Status: Completed
• Phase: N/A
• First received: August 10, 2009
• Last updated: February 14, 2012
• Start date: May 2010
• Est. completion date: January 2012

Study information

• Verified date: February 2012
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Nausea
• Postoperative Nausea and Vomiting
• Vomiting

Intervention

Drug:
• Aprepitant
80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery
• Aprepitant placebo
80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pennsylvania

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		72 hours	No