Status:

COMPLETED

Comparison of Aprepitant Versus Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Lead Sponsor:

Drexel University

Collaborating Sponsors:

Merck Sharp & Dohme LLC

Conditions:

Nausea

Vomiting

Eligibility:

All Genders

18-65 years

Phase:

NA

Brief Summary

The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for post-operati...

Detailed Description

Aprepitant, a selective antagonist of neurokinin-1 (NK-1) receptors, blocks the emetic effects of substance P. NK-1 receptors are found on vagal afferents in the gastrointestinal tract and in the nucl...

Eligibility Criteria

Inclusion

  • Between 18 and 65 years of age
  • American Society of Anesthesiology (ASA) physical status 1-3
  • If on oral contraceptive, must be willing to use back up method for 1 month
  • Must have 2 risk factors for PONV

Exclusion

  • History of vomiting due to middle ear infection, nervous system disorder, or other condition
  • Procedure less than 1 hour
  • Pregnant or breast feeding
  • Antiemetic medication in previous 24 hours
  • Narrow-angle glaucoma
  • Allergic to belladonna alkaloids
  • Hypersensitive to barbiturates
  • Prostate hypertrophy
  • Severe hepatic disease
  • On chemotherapy taking aprepitant
  • Fever
  • Sepsis
  • Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin

Key Trial Info

Start Date :

February 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

March 1 2010

Estimated Enrollment :

115 Patients enrolled

Trial Details

Trial ID

NCT00717054

Start Date

February 1 2008

End Date

March 1 2010

Last Update

May 20 2014

Active Locations (1)

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1

Hahnemann University Hospital

Philadelphia, Pennsylvania, United States, 19102