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

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

This study is currently recruiting participants.
Verified by University of Pittsburgh, October 2008
First Received: April 15, 2008 Last Updated: October 7, 2008

Sponsor: University of Pittsburgh
Collaborator: Merck

Information provided by: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00659945

Purpose
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.

Condition Intervention Phase
Postoperative Nausea and Vomiting (PONV)
Drug: Aprepitant plus Ondansetron
Drug: Ondansetron plus placebo
Phase IV

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


Arms Assigned Interventions
1: Active Comparator Drug: Aprepitant plus Ondansetron
Aprepitant plus Ondansetron
2: Placebo Comparator Drug: Ondansetron plus placebo
Ondansetron plus placebo
Eligibility


Ages Eligible for Study: 18 Years to 65 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: Yes

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
Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00659945


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


Locations
United States, Pennsylvania
UPMC Magee Women's Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Principal Investigator: Manuel C Vallejo, MD
Sub-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

Sponsors and Collaborators
University of Pittsburgh
Merck
Investigators
Principal Investigator: Manuel C Vallejo, MD Physician Services Division (UPP and CMI) / UPP / Anesthesiology and Pain Medicine

More Information

No publications provided

Responsible Party: Physician Services Division (UPP and CMI) / UPP / Anesthesiology and Pain Medicine ( Manuel C. Vallejo, MD / Associate Professor/University Faculty Member )
Study ID Numbers: PRO07070325
Study First Received: April 15, 2008
Last Updated: October 7, 2008
ClinicalTrials.gov Identifier: NCT00659945 History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Postoperation, nausea, vomiting, anesthesia, plastic surgery



Additional relevant MeSH terms:
Neurotransmitter Agents
Vomiting
Signs and Symptoms, Digestive
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Antiemetics
Signs and Symptoms
Serotonin Antagonists
Pathologic Processes
Therapeutic Uses
Antipruritics
Nausea
Ondansetron
Dermatologic Agents
Aprepitant
Postoperative Nausea and Vomiting
Tranquilizing Agents
Gastrointestinal Agents
Central Nervous System Depressants
Antipsychotic Agents
Pharmacologic Actions
Serotonin Agents
Postoperative Complications
Autonomic Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents

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