N/A
N=115
Comparison of Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting
Nausea · Vomiting
Bottom Line
View on ClinicalTrials.gov: NCT00659737 ↗Enrolled (actual)
115
Serious AEs
0.0%
Results posted
Apr 2014
Primary outcome: Primary: Number of Participants With Postoperative Nausea and Vomiting — 28; 34 participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Aprepitant (Drug); Scopolamine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Drexel University College of Medicine
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Postoperative Nausea and Vomiting |
28; 34 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00659737). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.