Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy

• Status: Terminated
• Trial end date: 2011-10-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mayo Clinic
• Treatments: Aprepitant; Fosaprepitant

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