Comparison of 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 Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
|Official Title:||A Randomized, Double-blind Comparison of Oral Aprepitant Alone Versus Oral Aprepitant and Transdermal Scopolamine for Preventing Postoperative Nausea and Vomiting|
- Number of Participants With Postoperative Nausea and Vomiting [ Time Frame: 0-24 hours ] [ Designated as safety issue: No ]
|Study Start Date:||April 2008|
|Study Completion Date:||March 2010|
|Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Placebo Comparator: Aprepitant
Oral Aprepitant pill and placebo transdermal patch at least 1 hour prior to surgical procedure.
Emend (Aprepitant) + Placebo
Other Name: Emend (Aprepitant) + Placebo
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 Name: Scopolamine + Emend (Aprepitant)
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00659737
|United States, Pennsylvania|
|Hahnemann University Hospital|
|Philadelphia, Pennsylvania, United States, 19102|
|Study Director:||Jay Horrow, MD||Drexel University College of Medicine|