Status:
COMPLETED
Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Lead Sponsor:
Drexel University College of Medicine
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Nausea
Vomiting
Eligibility:
All Genders
18-65 years
Phase:
NA
Brief Summary
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 hospit...
Detailed Description
Postoperative nausea and vomiting (PONV) is a serious problem complicating surgery. PONV has an overall incidence of 30% and a 70% incidence in high-risk patients. PONV yields unplanned hospital admis...
Eligibility Criteria
Inclusion
- Patient must be between 18 and 65 years of age.
- Patient's ASA (American Society of Anesthesiologist) 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
- 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
- Tolbutamide
- 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.
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT00659737
Start Date
April 1 2008
End Date
March 1 2010
Last Update
May 15 2014
Active Locations (1)
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1
Hahnemann University Hospital
Philadelphia, Pennsylvania, United States, 19102