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

NCT ID: NCT00956215

Last Updated: 2012-02-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 125 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-05-31
• Study Completion Date: 2012-01-31

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.

Conditions

Nausea; Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aprepitant

Intervention Type: DRUG

80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery

80 mg of placebo

. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia.

Group Type: PLACEBO_COMPARATOR

Aprepitant placebo

Intervention Type: DRUG

80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.

Interventions

Aprepitant

80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery

Intervention Type: DRUG

Aprepitant placebo

80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Pennsylvania

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ashish Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

University of Pennsylvania

Locations

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Countries

United States

Other Identifiers

Emend

Identifier Type: -

Identifier Source: org_study_id