Full Text View
Tabular View
No Study Results Posted
Related Studies
A Randomized, Double-Blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
This study is currently recruiting participants.
Study NCT00659737   Information provided by Drexel University
First Received: April 8, 2008   Last Updated: April 6, 2009   History of Changes

April 8, 2008
April 6, 2009
April 2008
September 2008   (final data collection date for primary outcome measure)
The outcomes measured include the incidences of nausea, vomiting, and their composite, as well as the need for rescue medication, and incidence of unplanned hospital admission; finally, the duration of PACU stay serves as an additional outcome variable. [ Time Frame: Arrival at PACU, and 10, 20, 30, 40, 50, and 60 minutes after arrival. ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00659737 on ClinicalTrials.gov Archive Site
 
 
 
A Randomized, Double-Blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
A Randomized, Double-Blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Recent evidence suggests multiple drug therapy is superior to single agents. The study compares the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for PONV treated with oral aprepitant with or without transdermal scopolamine preoperatively.

 
 
Interventional
Supportive Care, Randomized, Double Blind (Subject, Investigator), Parallel Assignment
  • Nausea
  • Vomiting
  • Drug: Emend (Aprepitant) + Placebo
  • Drug: Scopolamine + Emend (Aprepitant)
  • Active Comparator: Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.
  • Active Comparator: Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
120
 
September 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patient must be between 18 and 65 years of age.
  • Patient's ASA class must be between 1 and 3.
  • If patient is currently on oral contraceptive to prevent pregnancy, she must be willing to use a back up form of birth control for one month post study.
  • Patient must have 1 FACTOR to qualify

    • Female Sex
    • History of PONV
    • Motion Sickness
    • Non-Smoker
    • Intended Use of Post Operative Opioids

Exclusion Criteria:

  • Patients with a history of vomiting due to middle ear infection, nervous system disorder, or any other condition.
  • The surgical procedure is less than 1 hour.
  • The patient is pregnant or breast feeding.
  • The patient has taken antiemetic medication in previous 24 hours.
  • Patients with narrow-angle glaucoma.
  • Allergy to belladonna alkaloids.
  • Hypersensitivity to barbiturates.
  • Patient taking any of the following medications:

    • Orap
    • Seldane
    • Hismanal
    • Propulsid
    • Phenytoin
    • Phenothiazines
    • Tricyclic Antidepressants
    • Meperidine
    • Tolbutammide
    • Aluminum and Magnesium Trisilicate-containing Antacids
    • Anti-Cholinergics
    • Coumadin
  • Male patients with prostate hypertrophy.
  • Patients with severe hepatic disease.
  • Patients on Chemotherapy and taking Aprepitant.
  • Patients with fever.
  • Patients with sepsis.
Both
18 Years to 65 Years
No
Contact: Michael Green, DO 215-762-1524 Michael.Green@DrexelMed.edu
United States
 
NCT00659737
Michael Green, DO, Drexel University College of Medicine
20071433
Drexel University College of Medicine
Merck
Study Director: Jay Horrow, MD Drexel University College of Medicine
Drexel University
March 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP