Status:
TERMINATED
Aprepitant for Prevention of Postoperative Nausea and Vomiting in Elective Hysterectomy
Lead Sponsor:
Mayo Clinic
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
FEMALE
18+ years
Phase:
PHASE4
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 hyst...
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...
Eligibility Criteria
Inclusion
- Scheduled for elective hysterectomy at Mayo Clinic in Arizona
- ASA I, II, or III
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2011
Estimated Enrollment :
256 Patients enrolled
Trial Details
Trial ID
NCT00888329
Start Date
July 1 2007
End Date
October 1 2011
Last Update
March 30 2012
Active Locations (1)
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1
Mayo Clinic
Phoenix, Arizona, United States, 85054