Aprepitant for Post-operative Nausea

Overview

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.

Full Title of Study: “Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: November 2010

Interventions

  • Procedure: Aprepitant
    • 40 mg po pre-op
  • Drug: Placebo
    • Orally, pre-op

Arms, Groups and Cohorts

  • Active Comparator: Aprepitant
  • Placebo Comparator: Placebo

Clinical Trial Outcome Measures

Primary 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwell Health
  • Collaborator
    • Staten Island University Hospital
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Michael B Silverberg, MD, Principal Investigator, Staten Island University Hospital

References

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.

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