Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery - Full Text View

Sponsor:	University of Pittsburgh
Collaborator:	Merck
Information provided by (Responsible Party):	Manuel C. Vallejo, 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	Drug: Aprepitant plus Ondansetron Drug: Ondansetron plus placebo	Phase 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver) Primary Purpose: Prevention
Official Title:	Efficacy of Pre-operative Aprepitant Plus Ondansetron vs Ondansetron Plus Placebo in Patients at Moderate-to-High Risk Post-operative Nausea (PONV) Undergoing Ambulatory Plastic Surgery

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting Plastic and Cosmetic Surgery

Drug Information available for: Ondansetron hydrochloride Ondansetron Aprepitant Fosaprepitant

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Number of Participants Having Post-operative Emesis and Nausea. [ Time Frame: 48 hours post surgery ] [ Designated as safety issue: No ]
Postoperative emesis was measured as present or not present (nominal data) and analyzed with Chi-square; Comparison of nausea severity was performed in two ways. In those patients who exhibited nausea VRS>0, a worst nausea score for each patient was defined as the highest nausea score recorded over the 48 hours. Mann-Whitney rank sum test was used to compare worst nausea scores. Multivariate Analysis of Variance (MANOVA) was used to determine if the mean VRS (Verbal Rating Scale) score over time was significant between the two groups.

Enrollment:	150
Study Start Date:	June 2008
Study Completion Date:	June 2010
Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: 1 Pre-op Aprepitant plus Ondansetron for PONV prophylaxis in patients undergoing outpatient plastic surgery	Drug: Aprepitant plus Ondansetron Aprepitant plus Ondansetron Other Name: Emend
Placebo Comparator: 2 Pre-op Placebo plus Ondansetron for PONV prophylaxis in patients undergoing outpatient plastic surgery	Drug: Ondansetron plus placebo Ondansetron plus placebo Other Name: Zofran

Show Detailed Description

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

Locations

United States, Pennsylvania
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213

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:	Manuel C. Vallejo, Professor, Dept. of Anesthesiology, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00659945 History of Changes
Other Study ID Numbers:	PRO07070325
Study First Received:	April 15, 2008
Results First Received:	August 10, 2011
Last Updated:	November 2, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

Postoperation, nausea, vomiting, anesthesia, plastic surgery

Additional relevant MeSH terms:

Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Aprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions

Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents
Antipruritics
Dermatologic Agents
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Anti-Anxiety Agents

ClinicalTrials.gov processed this record on May 23, 2012