N/A N=115 Randomized Triple-blind Treatment

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

Nausea · Vomiting

Bottom Line

View on ClinicalTrials.gov: NCT00717054 ↗

Enrolled (actual)

115

Serious AEs

0.0%

Results posted

Apr 2014

Primary outcome: Primary: Number of Participants With Nausea and Vomiting — 24; 29 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
Primary completion: Mar 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Nausea and Vomiting	24; 29	—
SECONDARY Number of Participants With Nausea and Vomiting in PACU	35; 39	—
SECONDARY Total Vomiting	5; 2	—
SECONDARY Need for Antiemetic Medication	23; 21	—

Summary

The purpose of this study is to compare the incidence of nausea, vomiting, need for rescue medication, prolonged PACU time, and unplanned hospital admission in patients with high risk for post-operative nausea and vomiting (PONV) treated with oral aprepitant with or without transdermal scopolamine preoperatively.

Eligibility Criteria

Inclusion Criteria

Between 18 and 65 years of age
American Society of Anesthesiology (ASA) physical status 1-3
If on oral contraceptive, must be willing to use back up method for 1 month
Must have 2 risk factors for PONV

Exclusion Criteria

History of vomiting due to middle ear infection, nervous system disorder, or other condition
Procedure less than 1 hour
Pregnant or breast feeding
Antiemetic medication in previous 24 hours
Narrow-angle glaucoma
Allergic to belladonna alkaloids
Hypersensitive to barbiturates
Prostate hypertrophy
Severe hepatic disease
On chemotherapy taking aprepitant
Fever
Sepsis
Taking any of the following medications: Orap, Seldane, Hismanal, Propulsid, Phenytoin, Phenothiazines, Tricyclic antidepressants, Meperidine, Tolbutamide, Aluminum and Magnesium containing Antacids, Anti-cholinergics, Coumadin

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Data sourced from ClinicalTrials.gov (NCT00717054). 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.