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Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery

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ClinicalTrials.gov Identifier: NCT00659945
Recruitment Status : Completed
First Posted : April 17, 2008
Results First Posted : December 7, 2011
Last Update Posted : February 6, 2013
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Manuel C. Vallejo, University of Pittsburgh

Brief 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.


Condition or disease Intervention/treatment Phase
Postoperative Nausea and Vomiting Drug: Aprepitant plus Ondansetron Drug: Ondansetron plus placebo Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
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
Study Start Date : June 2008
Actual Primary Completion Date : November 2009
Actual Study Completion Date : June 2010

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Number of Participants Having Post-operative Emesis and Nausea. [ Time Frame: 48 hours post surgery ]
    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.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00659945


Locations
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United States, Pennsylvania
UPMC Magee Women's Hospital
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: Manuel C Vallejo, MD Physician Services Division (UPP and CMI) | UPP | Anesthesiology and Pain Medicine

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Responsible Party: Manuel C. Vallejo, Professor, Dept. of Anesthesiology, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00659945     History of Changes
Other Study ID Numbers: PRO07070325
First Posted: April 17, 2008    Key Record Dates
Results First Posted: December 7, 2011
Last Update Posted: February 6, 2013
Last Verified: February 2013
Keywords provided by Manuel C. Vallejo, University of Pittsburgh:
Postoperation, nausea, vomiting, anesthesia, plastic surgery
Additional relevant MeSH terms:
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Nausea
Vomiting
Postoperative Nausea and Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms
Postoperative Complications
Pathologic Processes
Ondansetron
Aprepitant
Fosaprepitant
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
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
Neurokinin-1 Receptor Antagonists