- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00659737
Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
May 1, 2014 updated by: Drexel University College of Medicine
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.
Study Overview
Status
Completed
Intervention / Treatment
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 admission, pulmonary aspiration, esophageal rupture, electrolyte abnormalities, dehydration, and delayed discharge from the postanesthesia care unit (PACU).
Additional use of resources costs the health care industry hundreds of millions of dollars annually.
Patient satisfaction is greatly improved when PONV is prevented.4
PONV etiology is multifactorial and the treatment is multimodal.
Study Type
Interventional
Enrollment (Actual)
115
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Philadelphia, Pennsylvania, United States, 19102
- Hahnemann University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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 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
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Aprepitant
Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo |
40mg tablet
Other Names:
|
Active Comparator: Scopolamine
Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure.
|
1.5 mg patch delivering transdermally in vivo approx.
1.0mg over 3 days
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of Participants With Postoperative Nausea and Vomiting
Time Frame: 0-24 hours
|
0-24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Director: Jay Horrow, MD, Drexel University College of Medicine
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2008
Primary Completion (Actual)
March 1, 2010
Study Completion (Actual)
March 1, 2010
Study Registration Dates
First Submitted
April 8, 2008
First Submitted That Met QC Criteria
April 14, 2008
First Posted (Estimate)
April 16, 2008
Study Record Updates
Last Update Posted (Estimate)
May 15, 2014
Last Update Submitted That Met QC Criteria
May 1, 2014
Last Verified
September 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Postoperative Complications
- Signs and Symptoms, Digestive
- Nausea
- Vomiting
- Postoperative Nausea and Vomiting
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Muscarinic Antagonists
- Cholinergic Antagonists
- Cholinergic Agents
- Antiemetics
- Gastrointestinal Agents
- Adjuvants, Anesthesia
- Mydriatics
- Neurokinin-1 Receptor Antagonists
- Aprepitant
- Fosaprepitant
- Scopolamine
- Butylscopolammonium Bromide
Other Study ID Numbers
- 20071433
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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