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

Sponsor:	University of Pennsylvania
Information provided by (Responsible Party):	Mary Hammond, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00956215

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:

MedlinePlus related topics: Nausea and Vomiting Obesity

Drug Information available for: Aprepitant

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 ]

Estimated Enrollment:	134
Study Start Date:	May 2010
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	December 2011 (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

Contacts

Contact: Mary S. Hammond, BSN

215-662-3772

mary.hammond@uphs.upenn.edu

Locations

United States, Pennsylvania
University of Pennsylvania	Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Mary S. Hammond, BSN 215-662-3772 mary.hammond@uphs.upenn.edu
Principal Investigator: Ashish Sinha, MD

Sponsors and Collaborators

University of Pennsylvania

Investigators

Principal Investigator:

Ashish Sinha, MD

University of Pennsylvania

More Information

No publications provided

Responsible Party:	Mary Hammond, Ashish Sinha, MD Primary Investigator, University of Pennsylvania
ClinicalTrials.gov Identifier:	NCT00956215 History of Changes
Other Study ID Numbers:	Emend
Study First Received:	August 10, 2009
Last Updated:	November 17, 2011
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 February 09, 2012