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Aprepitant for PONV Prophylaxis in Outpatient Plastic Surgery

NCT00659945 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2013-02-06

Study results available
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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.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Aprepitant plus Ondansetron

Aprepitant plus Ondansetron

DRUG

Ondansetron plus placebo

Ondansetron plus placebo

Sponsors & Collaborators

Principal Investigators

  • Manuel C Vallejo, MD · Physician Services Division (UPP and CMI) | UPP | Anesthesiology and Pain Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2009-11-30
Completion
2010-06-30

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00659945 on ClinicalTrials.gov