Postoperative Nausea and VomitingNCT02966041
Prophylactic Ondansetron in Post-op Cardiac Surgery Patients to Prevent Post-operative Nausea and Vomiting
A study testing Ondansetron and Saline in people with Postoperative Nausea and Vomiting, run by University of British Columbia at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Postoperative Nausea and Vomiting
- What is being tested?
- Ondansetron and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 186 participants
- Where
- 1 siteCanada
- Study dates
- 6 Mar 2018to 11 Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Double-blinded, Randomized Control Trial of Prophylactic Ondansetron in a Post-operative Cardiac Surgery Population for Post-operative Nausea and Vomiting
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.
Read the 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
- Conditions
- Postoperative Nausea and Vomiting
- Being tested
- Ondansetron, Saline
- Keywords
- Postoperative Nausea and Vomiting, PONV, CSICU, post-cardiac surgery, cardiac intensive care unit
- Medical subject headings
- Postoperative Nausea and Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
Also called Zofran
Ondansetron/Zofran is an antiemetic drug used to prevent and treat nausea and vomiting.
SalineDrug
Also called Placebo Comparator: 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.
| Study group | Role | What they receive |
|---|---|---|
| Ondansetron | Experimental | Ondansetron 4mg IV at time of discontinuation of Propofol Infusion Receives: Drug: Ondansetron |
| Saline | Placebo comparator | 2 mL IV Normal Saline at time of discontinuation of Propofol Infusion Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: First 24 hours post-extubation
Secondary outcomes (7)
Incidence of Rescue PONV medication administration
How many participants received rescue post-operative nausea and vomiting medication post-extubation after surgery.
Measured: First 24 hours post-extubation
Time to first dose of rescue PONV medication
Time of administration of first dose of rescue post-operative nausea and vomiting medication
Measured: First 24 hours post-extubation
Dose of any Rescue PONV medication
Dose of administered rescue post-operative nausea and vomiting medication after extubation.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: First 24 hours post-extubation
Incidence of ventricular arrhythmias
Any sustained Ventricular Arrhythmias (i.e. lasting greater than 30 seconds)
Measured: first 24 hours post-extubation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2016 (estimated)
- Study start6 Mar 2018
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative Nausea and VomitingStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 186 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matthew Coley, University of British Columbia
- Investigators
- Matthew Coley, MD, Principal investigator, University of British ColumbiaErica Wang, PharmD, Study chair, University of British ColumbiaCynthia Yarnold, MD, Study chair, University of British ColumbiaStephan Schwarz, MD, Study chair, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02966041
- Sponsor's protocol ID
- H15-00675
- Status last verified
- Oct 2018
- First submitted
- 25 Oct 2016
- Last updated
- 15 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32925337
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blinded, Randomized Control Trial of Prophylactic Ondansetron in a Post-operative Cardiac Surgery Population for Post-operative Nausea and Vomiting
- ClinicalTrials.gov ID
- NCT02966041
- Acronym / sponsor ID
- H15-00675
- Conditions
- Postoperative Nausea and Vomiting
- Keywords
- Postoperative Nausea and Vomiting, PONV, CSICU, post-cardiac surgery, cardiac intensive care unit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 186 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 17 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ondansetron | Experimental | Drug: OndansetronOndansetron 4mg IV at time of discontinuation of Propofol Infusion |
| Saline | Placebo comparator | Drug: Saline2 mL IV Normal Saline at time of discontinuation of Propofol Infusion |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Elective (outpatient) and urgent (inpatient) cardiac surgery procedures requiring cardiopulmonary bypass, including:
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OndansetronAlso: ZofranOndansetron/Zofran is an antiemetic drug used to prevent and treat nausea and vomiting. | Drug | Ondansetron |
| SalineAlso: Placebo Comparator: SalineNormal 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. | Drug | Saline |
Primary outcome
Occurrence of Post-operative Nausea and Vomiting (PONV)
Time frame: First 24 hours post-extubation
Measured by asking the patient hourly to assess their post operative nausea and vomiting using a 10-point verbal Likert rating scale.
7 secondary outcomes
Incidence of Rescue PONV medication administration
Time frame: First 24 hours post-extubation
Time to first dose of rescue PONV medication
Time frame: First 24 hours post-extubation
Dose of any Rescue PONV medication
Time frame: First 24 hours post-extubation
Time to first report of nausea or first vomit post-operatively
Time frame: First 24 hours post-extubation
Incidence of Post-operative nausea without vomiting
Time frame: First 24 hours post-extubation
Severity Post-operative nausea without vomiting
Time frame: First 24 hours post-extubation
Incidence of ventricular arrhythmias
Time frame: first 24 hours post-extubation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2018.
- Derived from this study: PubMed 32925337Wang 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.
- Individual participant dataSharing planned: Undecided
Related trials for Postoperative Nausea and Vomiting
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Coley, MD principal investigator
University of British Columbia
Erica Wang, PharmD study chair
University of British Columbia
Cynthia Yarnold, MD study chair
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ondansetron and Saline in people with Postoperative Nausea and Vomiting, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Post-operative Nausea and Vomiting (PONV) (time frame: First 24 hours post-extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02966041, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2018.