Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy



Status:Archived
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:July 2007
End Date:November 2011

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Prevention of Postoperative Nausea and Vomiting in a Gynecologic Surgery Population: A Randomized Placebo Controlled Trial of Aprepitant NK-1-receptor Antagonist


The purpose of the study is to determine whether 40 mg aprepitant administered before
surgery is effective for preventing vomiting in the first 24 hours after surgery in women
undergoing elective hysterectomy.


Postoperative nausea and vomiting (PONV) is the most frequent side effect after anesthesia,
occurring in approximately 30% of unselected patients, and can be increased up to 70% in
certain populations and procedures. Despite screening for patients at high risk for PONV,
current prophylactic interventions fail to completely eliminate PONV for a substantial
number of patients, leading to dehydration, electrolyte imbalance, prolonged
hospitalizations, multiple doses of rescue therapy, and readmissions to the hospital (2).
Aprepitant (Emend) is the first neurokin-1-receptor antagonist in a new class of
antiemetics, which has already demonstrated powerful additive effects when combined with
dexamethasone and a 5-HT3 to prevent both acute and delayed chemotherapy-induced nausea and
vomiting (CINV). Early studies have also suggested it may useful in the prevention of
postoperative nausea and vomiting (PONV).

Patients undergoing elective inpatient or outpatient hysterectomy will be offered enrollment
in this prospective, randomized, double blinded, placebo controlled trial. Subjects will
receive Aprepitant vs. placebo prior to induction of standardized anesthesia. Postoperative
nausea (assessed with a VRS), vomiting, and use of rescue antiemetic therapy will be
documented over a 48h period. Additionally, hospitalization days and readmissions for PONV
will be compared. Adverse events will be reported to the IRB and manufacturer. By reducing
PONV in a group of high risk patients, we anticipate a demonstrated decrease in rescue
antiemetic costs and hospitalization days for PONV related issues.


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Phoenix, Arizona 85054
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Phoenix, AZ
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