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Aprepitant Versus Ondansetron in Preoperative Triple-therapy Treatment of Nausea and Vomiting

NCT01474915 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 122

Last updated 2013-12-03

Study results available
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Summary

This study is being done to determine the efficacies of two preventative drug combinations for postoperative nausea and vomiting in patients undergoing neurosurgery. The aim of this study is to compare the efficacy of using aprepitant instead of ondansetron in combination with dexamethasone and promethazine for post-operative nausea and vomiting prophylaxis. By completing this comparison study investigators will determine the most efficacious drug combination which will allow us to enhance the overall comfort and satisfaction of neurosurgical patients in the immediate postoperative period.

Conditions

  • Postoperative Nausea and Vomiting (PONV)
  • Nausea

Interventions

DRUG

Aprepitant

Subject will receive 40 mg of Aprepitant versus placebo PO before anesthesia induction

DRUG

Ondansetron

Subject will receive 4 mg of Ondansetron IV versus placebo around anesthesia induction

DRUG

Promethazine

Subject will receive 25 mg of Promethazine IV around anesthesia induction

DRUG

Dexamethasone

Subject will receive 10 mg of Dexamethasone IV around anesthesia induction

Sponsors & Collaborators

  • Sergio Bergese

    lead OTHER

Principal Investigators

  • Sergio D Bergese, M.D. · Ohio State University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2012-12-31
Completion
2013-04-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT01474915 on ClinicalTrials.gov