Clinical trial NCT02966041: Prophylactic Ondansetron in Post-op Cardiac Surgery Patients to Prevent Post-operative Nausea and Vomiting
Official title: A Double-blinded, Randomized Control Trial of Prophylactic Ondansetron in a Post-operative Cardiac Surgery Population for Post-operative Nausea and Vomiting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Nausea and Vomiting
Keywords: Postoperative Nausea and Vomiting
PONV
CSICU
post-cardiac surgery
cardiac intensive care unit
Lead sponsor: University of British Columbia
Sponsor class: OTHER
First posted: 2016-11-17
Enrollment: 186
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Post-operative nausea and vomiting (PONV) is a significant source of morbidity for patients undergoing general anesthesia, and in particular, patients undergoing cardiac anesthesia. Despite its common occurrence, literature on PONV prophylaxis in the cardiac surgical population is limited relative to other surgical populations.

A rational approach to preventing PONV would be to administer prophylaxis prior to extubation once post-operative sedation has ceased. This timing of administration would be more standardized across patients, as duration of surgery and time of extubation after surgery can vary considerably, rendering plasma levels of PONV prophylaxis agents highly variable across patients.

At St. Paul's Hospital, PONV prophylaxis has not been a routine part of cardiac anesthesia care. Furthermore, there are no standardized guidelines, and practice varies between care providers. Following surgery, patients recover from anesthesia and are extubated in the cardiac surgery ICU (CSICU). They are usually sedated on a propofol infusion for one to four hours after surgery until they are ready for extubation. When PONV occurs, the first line drug for treatment is ondansetron 4 mg. The investigators therefore propose the use of a single, prophylactic dose of ondansetron (4 mg IV), given at the time of propofol cessation. A randomized, double blinded placebo controlled model will be utilized

Eligibility 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

Primary outcomes:
measure: Occurrence of Post-operative Nausea and Vomiting (PONV)
timeFrame: First 24 hours post-extubation
Secondary outcomes:
measure: Incidence of Rescue PONV medication administration
timeFrame: First 24 hours post-extubation
measure: Time to first dose of rescue PONV medication
timeFrame: First 24 hours post-extubation
measure: Dose of any Rescue PONV medication
timeFrame: First 24 hours post-extubation
measure: Time to first report of nausea or first vomit post-operatively
timeFrame: First 24 hours post-extubation
measure: Incidence of Post-operative nausea without vomiting
timeFrame: First 24 hours post-extubation
measure: Severity Post-operative nausea without vomiting
timeFrame: First 24 hours post-extubation
measure: Incidence of ventricular arrhythmias
timeFrame: first 24 hours post-extubation
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: St. Paul's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Matthew Coley, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of British Columbia
name: Erica Wang, PharmD
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Cynthia Yarnold, MD
role: STUDY_CHAIR
affiliation: University of British Columbia
name: Stephan Schwarz, MD
role: STUDY_CHAIR
References:
citation: Wang EHZ, Sunderland S, Edwards NY, Chima NS, Yarnold CH, Schwarz SKW, Coley MA. A Single Prophylactic Dose of Ondansetron Given at Cessation of Postoperative Propofol Sedation Decreases Postoperative Nausea and Vomiting in Cardiac Surgery Patients: A Randomized Controlled Trial. Anesth Analg. 2020 Oct;131(4):1164-1172. doi: 10.1213/ANE.0000000000004730.