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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron | Experimental | Ondansetron 4mg IV at time of discontinuation of Propofol Infusion |
|
| Saline | Placebo Comparator | 2 mL IV Normal Saline at time of discontinuation of Propofol Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron | Drug | Ondansetron/Zofran is an antiemetic drug used to prevent and treat nausea and vomiting. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Post-operative Nausea and Vomiting (PONV) | Measured by asking the patient hourly to assess their post operative nausea and vomiting using a 10-point verbal Likert rating scale. | First 24 hours post-extubation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Rescue PONV medication administration | How many participants received rescue post-operative nausea and vomiting medication post-extubation after surgery. | First 24 hours post-extubation |
| Time to first dose of rescue PONV medication |
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Inclusion Criteria:
Elective (outpatient) and urgent (inpatient) cardiac surgery procedures requiring cardiopulmonary bypass, including:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Coley, MD | University of British Columbia | Principal Investigator |
| Erica Wang, PharmD | University of British Columbia | Study Chair |
| Cynthia Yarnold, MD | University of British Columbia | Study Chair |
| Stephan Schwarz, MD | University of British Columbia | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Paul's Hospital | Vancouver | British Columbia | V6Z 1Y6 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32925337 | Derived | 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. |
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| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009325 | Nausea |
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| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Saline | Drug | 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. |
|
|
Time of administration of first dose of rescue post-operative nausea and vomiting medication
| First 24 hours post-extubation |
| Dose of any Rescue PONV medication | Dose of administered rescue post-operative nausea and vomiting medication after extubation. | First 24 hours post-extubation |
| Time to first report of nausea or first vomit post-operatively | Time to first report of any nausea or vomiting after extubation post-operatively. | First 24 hours post-extubation |
| Incidence of Post-operative nausea without vomiting | Nurses both asked patients' for a nausea severity rating and recorded any vomiting hourly. | First 24 hours post-extubation |
| Severity Post-operative nausea without vomiting | Severity of post-operative nausea without vomiting based on a 10-point likert scale, recorded hourly. | First 24 hours post-extubation |
| Incidence of ventricular arrhythmias | Any sustained Ventricular Arrhythmias (i.e. lasting greater than 30 seconds) | first 24 hours post-extubation |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D014839 | Vomiting |
| D002227 |
| Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |