Aprepitant for Post-operative Nausea

This study has been completed.
Staten Island University Hospital
Information provided by (Responsible Party):
Northwell Health
ClinicalTrials.gov Identifier:
First received: November 24, 2009
Last updated: June 3, 2015
Last verified: June 2015
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.

Condition Intervention
Postoperative Nausea
Procedure: Aprepitant
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy

Resource links provided by NLM:

Further study details as provided by Northwell Health:

Primary Outcome Measures:
  • Post-operative Nausea and Vomiting [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    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.

Enrollment: 200
Study Start Date: November 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Aprepitant Procedure: Aprepitant
40 mg po pre-op
Other Name: Emend
Placebo Comparator: Placebo Drug: Placebo
Orally, pre-op
Other Name: Sugar pill


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01020903

United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
Northwell Health
Staten Island University Hospital
Principal Investigator: Michael B Silverberg, MD Staten Island University Hospital
  More Information

Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01020903     History of Changes
Other Study ID Numbers: 09-045 
Study First Received: November 24, 2009
Results First Received: May 8, 2014
Last Updated: June 3, 2015
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Postoperative Nausea and Vomiting
Pathologic Processes
Postoperative Complications
Signs and Symptoms
Signs and Symptoms, Digestive
Autonomic Agents
Gastrointestinal Agents
Molecular Mechanisms of Pharmacological Action
Neurokinin-1 Receptor Antagonists
Neurotransmitter Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 25, 2016