Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Information source: Drexel University
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea; Vomiting
Intervention: Aprepitant (Drug); Scopolamine (Drug)
Phase: N/A
Status: Completed
Sponsored by: Drexel University College of Medicine Official(s) and/or principal investigator(s): Jay Horrow, MD, Study Director, Affiliation: Drexel University College of Medicine
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 hospital admission in patients with high risk for PONV treated with oral
aprepitant with or without transdermal scopolamine preoperatively.
Clinical Details
Official title: A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care
Primary outcome: Number of Participants With Postoperative Nausea and Vomiting
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
Criteria:
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.
Locations and Contacts
Hahnemann University Hospital, Philadelphia, Pennsylvania 19102, United States
Additional Information
Starting date: April 2008
Last updated: May 1, 2014
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