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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT00956215
First received: August 10, 2009
Last updated: February 14, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Nausea
Vomiting
 Drug: Aprepitant
Drug: Aprepitant placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 125
Study Start Date: May 2010
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 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.
 Drug: Aprepitant
80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery
Placebo Comparator: 80 mg of placebo
. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia.
 Drug: Aprepitant placebo
80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00956215

Locations
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
Investigators
Principal Investigator: Ashish Sinha, MD University of Pennsylvania
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT00956215     History of Changes
Other Study ID Numbers: Emend
Study First Received: August 10, 2009
Last Updated: February 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pennsylvania:
post operative
obese

Additional relevant MeSH terms:
Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Aprepitant
 Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 16, 2013