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Aprepitant for Post-operative Nausea

Primary Purpose

Postoperative Nausea

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aprepitant
Placebo
Sponsored by
Northwell Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea

Eligibility Criteria

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

Inclusion Criteria:

  • Laparoscopic cholecystectomy patients.
  • Must be able to swallow a pill.

Exclusion Criteria:

  • Liver failure,
  • Age less than 18.
  • Pregnancy, breast-feeding.
  • Pre-op vomiting.
  • Allergy to aprepitant.
  • Need for post-op gastric drainage.
  • Use of drugs that interact with aprepitant.

Sites / Locations

  • Staten Island University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Aprepitant

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Post-operative Nausea and Vomiting
Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.

Secondary Outcome Measures

Full Information

First Posted
November 24, 2009
Last Updated
June 3, 2015
Sponsor
Northwell Health
Collaborators
Staten Island University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01020903
Brief Title
Aprepitant for Post-operative Nausea
Official Title
Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwell Health
Collaborators
Staten Island University Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Aprepitant
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Procedure
Intervention Name(s)
Aprepitant
Other Intervention Name(s)
Emend
Intervention Description
40 mg po pre-op
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sugar pill
Intervention Description
Orally, pre-op
Primary Outcome Measure Information:
Title
Post-operative Nausea and Vomiting
Description
Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Laparoscopic cholecystectomy patients. Must be able to swallow a pill. Exclusion Criteria: Liver failure, Age less than 18. Pregnancy, breast-feeding. Pre-op vomiting. Allergy to aprepitant. Need for post-op gastric drainage. Use of drugs that interact with aprepitant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Silverberg, MD
Organizational Affiliation
Staten Island University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
10365008
Citation
Diemunsch P, Schoeffler P, Bryssine B, Cheli-Muller LE, Lees J, McQuade BA, Spraggs CF. Antiemetic activity of the NK1 receptor antagonist GR205171 in the treatment of established postoperative nausea and vomiting after major gynaecological surgery. Br J Anaesth. 1999 Feb;82(2):274-6. doi: 10.1093/bja/82.2.274.
Results Reference
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Aprepitant for Post-operative Nausea

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