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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting

Conditions
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Nausea, Vomiting

Intervention / Treatment
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* Drug: Aprepitant
* Drug: Scopolamine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Aprepitant<br>Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure. Emend (Aprepitant) + Placebo | Drug: Aprepitant<br>* 40mg tablet<br>* Other names: Emend (Aprepitant) + Placebo;|
| Active Comparator: Scopolamine<br>Oral Aprepitant pill and Scopolamine transdermal patch at least 1 hour prior to surgical procedure. | Drug: Scopolamine<br>* 1.5 mg patch delivering transdermally in vivo approx. 1.0mg over 3 days<br>* Other names: Scopolamine + Emend (Aprepitant);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Postoperative Nausea and Vomiting |  | 0-24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Post-operative Nausea and Vomiting (PONV)