Status:
COMPLETED
Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Postoperative Nausea and Vomiting
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Hypothesis: Aprepitant plus ondansetron is more effective than ondansetron plus placebo for prevention of postoperative emesis in patients at moderate-to-high risk for PONV for up to 48 hours after su...
Detailed Description
We plan to enroll women and men undergoing outpatient plastic surgical procedures under general anesthesia. Patients who are scheduled for outpatient plastic surgery will be contacted by one of the in...
Eligibility Criteria
Inclusion
- Written informed consent
- ASA (American Society of Anesthesiologists physical status) 1-3
- Male and female Age 18 to 65 years
- Plastic surgical procedure (Breast, Face, Liposuction, etc., and excluding peripheral procedures such as hand surgery and limited-scope split-thickness skin grafts) of at least 1 hour in duration
- General anesthesia
- Presence of 2 (men)/3 (women) or more risk factors for PONV
- Ambulatory surgery with same-day discharge planned
Exclusion
- Patient refusal
- Patients who have received other antiemetics prior to their procedure
- History of allergy or sensitivity to study drugs
- Pregnancy - Patients are asked date of last menstrual period, use of birth control, tubal ligation, if they have had unprotected sexual intercourse and if they think if there is any possibility of being pregnant, and when appropriate, a pregnancy test will be obtained which is the standard of care at Magee-Womens Hospital.
- Patients with a history of chronic opioid use (chronic pain syndrome) as these patients will be less likely to have PONV
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT00659945
Start Date
June 1 2008
End Date
June 1 2010
Last Update
February 6 2013
Active Locations (1)
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1
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213