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

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aprepitant
Aprepitant placebo
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea focused on measuring post operative, obese

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

80mg of Aprepitant

80 mg of placebo

Arm Description

Patients will be randomized to receive 80mg of Aprepitant with 50 ml of water no later than 30 minutes before induction of anesthesia.

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

Outcomes

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.

Secondary Outcome Measures

Full Information

First Posted
August 10, 2009
Last Updated
February 14, 2012
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT00956215
Brief Title
Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
Acronym
PONV
Official Title
A Randomized and Placebo-Controlled Evaluation of Aprepitant for Decreasing the Incidence of Post-Operative Nausea and Vomiting (PONV) in Bariatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2012
Overall Recruitment Status
Completed
Study Start Date
May 2010 (undefined)
Primary Completion Date
January 2012 (Actual)
Study Completion Date
January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting
Keywords
post operative, obese

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
125 (Actual)

8. Arms, Groups, and Interventions

Arm Title
80mg of Aprepitant
Arm Type
Active Comparator
Arm Description
Patients will be randomized to receive 80mg of Aprepitant with 50 ml of water no later than 30 minutes before induction of anesthesia.
Arm Title
80 mg of placebo
Arm Type
Placebo Comparator
Arm Description
. Patients will be randomized to placebo with 50 ml of water no later than 30 minutes before induction of anesthesia.
Intervention Type
Drug
Intervention Name(s)
Aprepitant
Intervention Description
80 mg tablet of Aprepitant with 50 ml of water 30 minutes before surgery
Intervention Type
Drug
Intervention Name(s)
Aprepitant placebo
Intervention Description
80 mg placebo tablet with 50 ml of water no later than 30 minutes before induction of anesthesia.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ashish Sinha, MD
Organizational Affiliation
University of Pennsylvania
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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