Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy

Phase 4

Terminated

Conditions: Postoperative Nausea and Vomiting

Interventions: Drug: Placebo
Drug: Aprepitant

Registration Number: NCT00888329

Lead Sponsor: Mayo Clinic

Brief Summary: 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.

Detailed Description: 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.

Recruitment & Eligibility

Status: TERMINATED

Sex: Female

Target Recruitment: 256

Inclusion Criteria

Scheduled for elective hysterectomy at Mayo Clinic in Arizona
ASA I, II, or III

Exclusion Criteria

Pregnancy
Concomitant bowel surgery other than appendectomy
Hypersensitivity to study drug or rescue medication
Preoperative score for nausea greater than 4 out of 10 points
Severe hepatic insufficiency (Child-Pugh score > 9)
Any condition which impairs the patient's ability to complete study assessments
Intraoperative hemodynamic instability
ICU admission
Prolonged postoperative intubation
Rifampin, carbamazepine, phenytoin, or other drugs which strongly induce CYP3A4 activity
Other antiemetic within 12 hours prior to surgery
Participation in a clinical trial using an investigational product

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo
Aprepitant	Aprepitant	40 mg aprepitant

Primary Outcome Measures

Name	Time	Method
Number of Participants With Emesis	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.

Secondary Outcome Measures