Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

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 surgery.

Specific Aim: To determine the incidence of PONV during the first 48 hours after surgery; in patients who have received aprepitant plus ondansetron versus ondansetron plus placebo for up to 48 hours after surgery.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Aprepitant; Fosaprepitant; Ondansetron

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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