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Completed

NCT Number: NCT00956215

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

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.

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Key information

Conditions

Nausea Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aprepitant

Drug

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

Aprepitant Placebo

Drug

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

Primary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Registry information

Official study title

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

Acronym: PONV

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Aug 11, 2009
Registry last updated
Feb 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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