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Aprepitant for Post-operative Nausea

This study has been completed.
Sponsor:
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier:
NCT01020903
First received: November 24, 2009
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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, Caregiver, Investigator, Outcomes Assessor)
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:

U.S. FDA Resources

Further study details as provided by North Shore Long Island Jewish Health System:

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

Enrollment: 171
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01020903

Locations
United States, New York
Staten Island University Hospital
Staten Island, New York, United States, 10305
Sponsors and Collaborators
North Shore Long Island Jewish Health System
Staten Island University Hospital
Investigators
Principal Investigator: Michael B Silverberg, MD Staten Island University Hospital
  More Information

Publications:

Responsible Party: North Shore Long Island Jewish Health System
ClinicalTrials.gov Identifier: NCT01020903     History of Changes
Other Study ID Numbers: 09-045
Study First Received: November 24, 2009
Last Updated: May 7, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Nausea
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Vomiting
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 19, 2013