Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy
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|ClinicalTrials.gov Identifier: NCT00888329|
Recruitment Status : Terminated (Slow accrual.)
First Posted : April 27, 2009
Results First Posted : March 30, 2012
Last Update Posted : March 30, 2012
|Condition or disease||Intervention/treatment||Phase|
|Postoperative Nausea and Vomiting||Drug: Aprepitant Drug: Placebo||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||256 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Prevention of Postoperative Nausea and Vomiting in a Gynecologic Surgery Population: A Randomized Placebo Controlled Trial of Aprepitant NK-1-receptor Antagonist|
|Study Start Date :||July 2007|
|Primary Completion Date :||October 2011|
|Study Completion Date :||October 2011|
40 mg aprepitant
40 mg administered orally with a sip of water prior to anesthesia induction.
Other Name: Emend
Placebo Comparator: Placebo
- Number of Participants With Emesis [ Time Frame: 24 hours after emergence from anesthesia ]This is the number of participants who had an episode of vomiting within 24 hours after emergence from anesthesia.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00888329
|United States, Arizona|
|Phoenix, Arizona, United States, 85054|
|Principal Investigator:||Javier Magrina, MD||Mayo Clinic|