Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Postoperative Nausea and Vomiting

In brief

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.

Key facts

Study ID

NCT00888329

Run by

Mayo Clinic

People needed

256

Starts

2007-07-01

Expected to finish

2011-10-01

Last updated by the study team

2012-03-30

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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

Where it is running

• Mayo Clinic — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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