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Aprepitant for Post-operative Nausea

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01020903
First Posted: November 26, 2009
Last Update Posted: June 4, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Staten Island University Hospital
Information provided by (Responsible Party):
Northwell Health
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 ]
    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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020903


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

Publications:
Responsible Party: Northwell Health
ClinicalTrials.gov Identifier: NCT01020903     History of Changes
Other Study ID Numbers: 09-045
First Submitted: November 24, 2009
First Posted: November 26, 2009
Results First Submitted: May 8, 2014
Results First Posted: June 4, 2015
Last Update Posted: June 4, 2015
Last Verified: June 2015

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