Clinical trial NCT00888329: Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Postoperative Nausea and Vomiting
Keywords: Elective hysterectomy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-04-27
Enrollment: 256
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Emesis
timeFrame: 24 hours after emergence from anesthesia
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Javier Magrina, MD
role: PRINCIPAL_INVESTIGATOR
References: