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

• Status: Completed
• Trial end date: 2018-07-11
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of British Columbia
• Treatments: Ondansetron

Criteria

Inclusion Criteria:

• Elective (outpatient) and urgent (inpatient) cardiac surgery procedures requiring cardiopulmonary bypass, including:

• Coronary artery bypass grafting (CABG)

• Valve surgery (ie. repair and/or replacement)

• CABG and valve surgery

Exclusion Criteria:

• Undergoing 'off-pump' CABG (not involving the cardiopulmonary bypass machine)

• With a contraindication to the study drug - including but not limited to congenital Long QT Syndrome, allergy to ondansetron, or a history of migraines

• Unable to understand the consent process, either due to language limitations or cognitive limitations if a translator or substitute decision maker is not available

• Receiving heart transplants, ventricular assist devices or on extra-corporeal membrane oxygenation (ECMO)

• Intubated for more than 12 hours post-operatively

• With a known history of PONV

• Sedated with dexmedatomine instead of propofol