Palonosetron Associated to Aprepitant in Prophylaxis of PONV

NCT02431286 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2015-05-01

No results posted yet for this study

Summary

The objective of this study is to investigate if aprepitant in association with palonosetron and dexamethasone could reduce the incidence of PONV in high-risk patients for this symptom, undergoing cancer surgery mastectomies.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Aprepitant

aprepitant will be administered in preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively

DRUG

Placebo

Placebo will be administered in the preoperative period; intravenous palonosetron and dexamethasone will be administered intraoperatively

DRUG

Dexamethasone

Dexamethasone and plonosetron will be administered intraoperatively in both groups, durong surgery

Sponsors & Collaborators

  • Instituto do Cancer do Estado de São Paulo

    lead OTHER

Principal Investigators

  • Hazem a Ashmawi, phD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-12-31
Completion
2015-12-31

Countries

  • Brazil

Study Locations

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Entities

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 NCT02431286 on ClinicalTrials.gov