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

Primary Purpose

Postoperative Nausea and Vomiting

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Ondansetron
Saline
Sponsored by
University of British Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Nausea and Vomiting focused on measuring Postoperative Nausea and Vomiting, PONV, CSICU, post-cardiac surgery, cardiac intensive care unit

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Paul's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ondansetron

Saline

Arm Description

Ondansetron 4mg IV at time of discontinuation of Propofol Infusion

2 mL IV Normal Saline at time of discontinuation of Propofol Infusion

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Incidence of Rescue PONV medication administration
How many participants received rescue post-operative nausea and vomiting medication post-extubation after surgery.
Time to first dose of rescue PONV medication
Time of administration of first dose of rescue post-operative nausea and vomiting medication
Dose of any Rescue PONV medication
Dose of administered rescue post-operative nausea and vomiting medication after 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.
Incidence of Post-operative nausea without vomiting
Nurses both asked patients' for a nausea severity rating and recorded any vomiting hourly.
Severity Post-operative nausea without vomiting
Severity of post-operative nausea without vomiting based on a 10-point likert scale, recorded hourly.
Incidence of ventricular arrhythmias
Any sustained Ventricular Arrhythmias (i.e. lasting greater than 30 seconds)

Full Information

First Posted
October 25, 2016
Last Updated
October 10, 2018
Sponsor
University of British Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT02966041
Brief Title
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

2. Study Status

Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
March 6, 2018 (Actual)
Primary Completion Date
July 11, 2018 (Actual)
Study Completion Date
July 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Nausea and Vomiting
Keywords
Postoperative Nausea and Vomiting, PONV, CSICU, post-cardiac surgery, cardiac intensive care unit

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
186 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ondansetron
Arm Type
Experimental
Arm Description
Ondansetron 4mg IV at time of discontinuation of Propofol Infusion
Arm Title
Saline
Arm Type
Placebo Comparator
Arm Description
2 mL IV Normal Saline at time of discontinuation of Propofol Infusion
Intervention Type
Drug
Intervention Name(s)
Ondansetron
Other Intervention Name(s)
Zofran
Intervention Description
Ondansetron/Zofran is an antiemetic drug used to prevent and treat nausea and vomiting.
Intervention Type
Drug
Intervention Name(s)
Saline
Other Intervention Name(s)
Placebo Comparator: Saline
Intervention Description
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.
Primary Outcome Measure Information:
Title
Occurrence of Post-operative Nausea and Vomiting (PONV)
Description
Measured by asking the patient hourly to assess their post operative nausea and vomiting using a 10-point verbal Likert rating scale.
Time Frame
First 24 hours post-extubation
Secondary Outcome Measure Information:
Title
Incidence of Rescue PONV medication administration
Description
How many participants received rescue post-operative nausea and vomiting medication post-extubation after surgery.
Time Frame
First 24 hours post-extubation
Title
Time to first dose of rescue PONV medication
Description
Time of administration of first dose of rescue post-operative nausea and vomiting medication
Time Frame
First 24 hours post-extubation
Title
Dose of any Rescue PONV medication
Description
Dose of administered rescue post-operative nausea and vomiting medication after extubation.
Time Frame
First 24 hours post-extubation
Title
Time to first report of nausea or first vomit post-operatively
Description
Time to first report of any nausea or vomiting after extubation post-operatively.
Time Frame
First 24 hours post-extubation
Title
Incidence of Post-operative nausea without vomiting
Description
Nurses both asked patients' for a nausea severity rating and recorded any vomiting hourly.
Time Frame
First 24 hours post-extubation
Title
Severity Post-operative nausea without vomiting
Description
Severity of post-operative nausea without vomiting based on a 10-point likert scale, recorded hourly.
Time Frame
First 24 hours post-extubation
Title
Incidence of ventricular arrhythmias
Description
Any sustained Ventricular Arrhythmias (i.e. lasting greater than 30 seconds)
Time Frame
first 24 hours post-extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Coley, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Erica Wang, PharmD
Organizational Affiliation
University of British Columbia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Cynthia Yarnold, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Stephan Schwarz, MD
Organizational Affiliation
University of British Columbia
Official's Role
Study Chair
Facility Information:
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
32925337
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.
Results Reference
derived

Learn more about this trial

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

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