Official Title: “A Randomized, Prospective, Placebo-Controlled, Double Blind Trial to Evaluate the Efficacy of Pre-op Aprepitant Plus Ondansetron vs Ondansetron Plus Placebo in Patients at Moderate-to-High Risk Post-op Nausea (PONV) Undergoing Ambulatory Plastic Surgery.”

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.

Study Type: Interventional

Study Design: Prevention, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: June 2009

Intervention(s) in this Clinical Trial

• Drug: Aprepitant plus Ondansetron
  • Aprepitant plus Ondansetron
• Drug: Ondansetron plus placebo
  • Ondansetron plus placebo

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
• Placebo Comparator: 2

Primary Measures

• Our primary endpoint will be the incidence of emesis at 48 hours after surgery.
  • Time Frame: 2 hrs before surgery to 48 after surgery
    Safety Issue?: No

Secondary Measures

• Secondary endpoints will include the incidence of nausea and emesis during the time periods measured above, the use and doses of rescue anti-emetics and analgesic requirements during these time periods.
  • Time Frame: These time periods will include immediately postoperation in the PACU and through 48 hours after surgery.
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Sponsor: University of Pittsburgh

Overall Clinical Trial Officials and Contacts

Manuel C Vallejo, MD Principal Investigator Physician Services Division (UPP and CMI) / UPP / Anesthesiology and Pain Medicine  

Overall Contact: Manuel C Vallejo, MD 412-641-4260 vallejomc@anes.upmc.edu

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00659945

Study ID Number: PRO07070325

ClinicalTrials.gov Identifier: NCT00659945

Health Authority: United States: Institutional Review Board