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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00956215

Acronym

PONV

Enrollment

125

Registered

2009-08-11

Start date

2010-05-31

Completion date

2012-01-31

Last updated

2012-02-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Nausea, Vomiting

Keywords

post operative, obese

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.

Interventions

DRUGAprepitant

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

DRUGAprepitant placebo

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026