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Effectiveness of Aprepitant in the Treatment of Postoperative Nausea and Vomiting (PONV) in Patients Undergoing Outpatient Plastic Surgery

Information source: University of Pittsburgh
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Postoperative Nausea and Vomiting (PONV)

Intervention: Aprepitant plus Ondansetron (Drug); Ondansetron plus placebo (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: University of Pittsburgh

Official(s) and/or principal investigator(s):
Manuel C Vallejo, MD, Principal Investigator, Affiliation: Physician Services Division (UPP and CMI) / UPP / Anesthesiology and Pain Medicine

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

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.

Clinical Details

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.

Study design: Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver), Primary Purpose: Prevention

Primary outcome: Our primary endpoint will be the incidence of emesis at 48 hours after surgery.

Secondary outcome: 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.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Locations and Contacts

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

UPMC Magee Women's Hospital, Pittsburgh, Pennsylvania 15213, United States; Recruiting
Manuel C Vallejo, MD, Principal Investigator
Shagufta Y Chaudhry, MD, Sub-Investigator
Brains Williams, MD, Sub-Investigator
Kenneth Shestak, MD, Sub-Investigator
Dennis Hurwitz, MD, Sub-Investigator
Peter Rubin, MD, Sub-Investigator
John Waters, MD, Sub-Investigator
Kaul Bupesh, MD, Sub-Investigator
Jonathan Williams, MD, Sub-Investigator
Patrica Dalby, MD, Sub-Investigator
Derick Davis, MD, Sub-Investigator
Ryan Romeo, MD, Sub-Investigator
Additional Information

Starting date: June 2008
Last updated: October 7, 2008

Page last updated: October 04, 2010

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