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Prophylactic Ondansetron in Post-op Cardiac Surgery Patients to Prevent Post-operative Nausea and Vomiting

NCT02966041 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 186

Last updated 2018-10-15

No results posted yet for this study

Summary

To evaluate the effectiveness of a prophylactic dose of ondansetron in decreasing the incidence of post-operative nausea and vomiting in cardiac surgery patients after cessation of post-operative sedation. In patients who have undergone open heart surgery, a single prophylactic dose of ondansetron 4 mg IV given at the time of discontinuing propofol sedation will result in a 50% reduction of the rate of post-operative nausea and vomiting in the first 24 post-operative hours compared to placebo.

Conditions

  • Postoperative Nausea and Vomiting

Interventions

DRUG

Ondansetron

Ondansetron/Zofran is an antiemetic drug used to prevent and treat nausea and vomiting.

DRUG

Saline

Normal saline is salt water and is acting as a placebo in this study. A placebo is an inactive substance that looks identical to the test drug, but it contains no therapeutic ingredient.

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Matthew Coley, MD · University of British Columbia

  • Erica Wang, PharmD · University of British Columbia

  • Cynthia Yarnold, MD · University of British Columbia

  • Stephan Schwarz, MD · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-03-06
Primary Completion
2018-07-11
Completion
2018-07-11

Countries

  • Canada

Study Locations

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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 NCT02966041 on ClinicalTrials.gov