Cardiac SurgeryNCT01151254
Comparison of Propofol Based Versus Volatile Based Anesthesia and Postoperative Sedation
A study testing Isoflurane/sevoflurane and Propofol in people with Cardiac Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
All patients undergoing cardiac surgery require intraoperative anesthesia and short-term postoperative sedation with anesthetic agents after the procedure when patient is in the intensive care unit (ICU). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cardiac Surgery
- What is being tested?
- Isoflurane/sevoflurane and Propofol
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 146 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2009to Jul 2013
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for coronary artery bypass graft surgery with good ventricular function (grade 1-2 ventricle)
- Signed informed consent
Who cannot join
- Patients undergoing valvular surgery
- Severe kidney or liver disease (creatinine > 2.5mg.dL-1 and bilirubin > 2 mg.dL-1)
- Patients with known hypersensitivity to any of the trial drugs (propofol, volatile anesthetics), e.g. propofol allergy or malignant hyperthermia (induced by volatile anesthetics)
- Patient with poorly controlled diabetes or on oral anti-diabetic medication (inhibit preconditioning caused by volatile anesthetics)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Propofol Based Anesthesia and Postoperative Sedation (PA) Versus Volatile Anesthetics Based Anesthesia and Postoperative Sedation (VA) in Cardiac Surgical Patients
All patients undergoing cardiac surgery require intraoperative anesthesia and short-term postoperative sedation with anesthetic agents after the procedure when patient is in the intensive care unit (ICU). The clinical data obtained so far are concentrating on intraoperative use volatile agents (preconditioning) resulting in better postoperative cardiac function and less release of biochemical markers of myocardial damage. There are no studies investigating whether postoperative use of volatile agents (post conditioning) in cardiac surgical population is improving outcomes. The aim of the present study is to compare total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and postoperative sedation in cardiac surgical population.
- Conditions
- Cardiac Surgery
- Being tested
- Isoflurane/sevoflurane, Propofol
- Keywords
- Cardiac Surgery, Sedation, Intensive care, Volatile anesthesia, Intravenous anesthesia, Pre and post conditioning after cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isoflurane/sevofluraneDrug
Also called 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane, 2,2,2-trifluoro-1-[trifluoromethyl]ethyl fluoromethyl ether
Volatile for sedation in the CVICU while intubated
PropofolOther
Also called Diprivan
Propofol for sedation in the CVICU
| Study group | Role | What they receive |
|---|---|---|
| PA-Intravenous Sedation | Active comparator | Propofol based total intravenous anesthesia and postoperative sedation Receives: Other: Propofol |
| Volatile sedation | Active comparator | Total inhalational anesthesia and postoperative sedation with the AnaConda device Receives: Drug: Isoflurane/sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
The composite primary end point of the trial will be the development of enzymatic signs of myocardial injury or MI, postoperative low output syndrome, or both. Enzymatic MI will be determined after obtaining serial measurements of troponin.
Measured: Measurements of troponin levels will be after induction of anesthesia (baseline) and at 0, 2, 4, 8, and 24 h after arrival into the ICU.
Secondary outcomes (4)
Quality of sedation
Measured: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Incidence of delirium
Measured: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Time to readiness for extubation, time to extubation
Measured: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Length of stay within ICU, readiness for discharge from the unit
Measured: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2010 (estimated)
- Study startSep 2009
- Primary completionJan 2012
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiac SurgeryStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 146 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marcin Wasowicz, MD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01151254
- Sponsor's protocol ID
- UHN REB 06-0159 B
- Status last verified
- Feb 2014
- First submitted
- 17 May 2010
- Last updated
- 12 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Wasowicz M, Jerath A, Luksun W, Sharma V, Mitsakakis N, Meineri M, Katznelson R, Yau T, Rao V, Beattie WS. Comparison of propofol-based versus volatile-based anaesthesia and postoperative sedation in cardiac surgical patients: a prospective, randomized, study. Anaesthesiol Intensive Ther. 2018;50(3):200-209. doi: 10.5603/AIT.a2018.0012. Epub 2018 Jun 18.
PubMed 29913033Pickworth T, Jerath A, DeVine R, Kherani N, Wasowicz M. The scavenging of volatile anesthetic agents in the cardiovascular intensive care unit environment: a technical report. Can J Anaesth. 2013 Jan;60(1):38-43. doi: 10.1007/s12630-012-9814-5. Epub 2012 Nov 7.
PubMed 23132045
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Propofol Based Anesthesia and Postoperative Sedation (PA) Versus Volatile Anesthetics Based Anesthesia and Postoperative Sedation (VA) in Cardiac Surgical Patients
- ClinicalTrials.gov ID
- NCT01151254
- Acronym / sponsor ID
- UHN REB 06-0159 B
- Conditions
- Cardiac Surgery
- Keywords
- Cardiac Surgery, Sedation, Intensive care, Volatile anesthesia, Intravenous anesthesia, Pre and post conditioning after cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 146 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 28 Jun 2010 (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.
All patients undergoing cardiac surgery require intraoperative anesthesia and short-term postoperative sedation with anesthetic agents after the procedure when patient is in the intensive care unit (ICU). The clinical data obtained so far are concentrating on intraoperative use volatile agents (preconditioning) resulting in better postoperative cardiac function and less release of biochemical markers of myocardial damage. There are no studies investigating whether postoperative use of volatile agents (post conditioning) in cardiac surgical population is improving outcomes. The aim of the present study is to compare total intravenous anesthesia and postoperative sedation versus total volatile anesthesia and postoperative sedation in cardiac surgical population.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PA-Intravenous Sedation | Active comparator | Other: PropofolPropofol based total intravenous anesthesia and postoperative sedation |
| Volatile sedation | Active comparator | Drug: Isoflurane/sevofluraneTotal inhalational anesthesia and postoperative sedation with the AnaConda device |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled for coronary artery bypass graft surgery with good ventricular function (grade 1-2 ventricle)
- Signed informed consent
Key exclusion criteria (4 listed)
- Patients undergoing valvular surgery
- Severe kidney or liver disease (creatinine > 2.5mg.dL-1 and bilirubin > 2 mg.dL-1)
- Patients with known hypersensitivity to any of the trial drugs (propofol, volatile anesthetics), e.g. propofol allergy or malignant hyperthermia (induced by volatile anesthetics)
- Patient with poorly controlled diabetes or on oral anti-diabetic medication (inhibit preconditioning caused by volatile anesthetics)
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 |
|---|---|---|
| Isoflurane/sevofluraneAlso: 2-chloro-2-(difluoromethoxy)-1,1,1-trifluoro-ethane, 2,2,2-trifluoro-1-[trifluoromethyl]ethyl fluoromethyl etherVolatile for sedation in the CVICU while intubated | Drug | Volatile sedation |
| PropofolAlso: DiprivanPropofol for sedation in the CVICU | Other | PA-Intravenous Sedation |
Primary outcome
The composite primary end point of the trial will be the development of enzymatic signs of myocardial injury or MI, postoperative low output syndrome, or both. Enzymatic MI will be determined after obtaining serial measurements of troponin.
Time frame: Measurements of troponin levels will be after induction of anesthesia (baseline) and at 0, 2, 4, 8, and 24 h after arrival into the ICU.
4 secondary outcomes
Quality of sedation
Time frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Incidence of delirium
Time frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Time to readiness for extubation, time to extubation
Time frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
Length of stay within ICU, readiness for discharge from the unit
Time frame: Post ICU arrival POD 0 to discharge (2hours to on average 5-7 days until discharge)
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 12 Feb 2014.
- Derived from this study: PubMed 29913033Wasowicz M, Jerath A, Luksun W, Sharma V, Mitsakakis N, Meineri M, Katznelson R, Yau T, Rao V, Beattie WS. Comparison of propofol-based versus volatile-based anaesthesia and postoperative sedation in cardiac surgical patients: a prospective, randomized, study. Anaesthesiol Intensive Ther. 2018;50(3):200-209. doi: 10.5603/AIT.a2018.0012. Epub 2018 Jun 18.
- Derived from this study: PubMed 23132045Pickworth T, Jerath A, DeVine R, Kherani N, Wasowicz M. The scavenging of volatile anesthetic agents in the cardiovascular intensive care unit environment: a technical report. Can J Anaesth. 2013 Jan;60(1):38-43. doi: 10.1007/s12630-012-9814-5. Epub 2012 Nov 7.
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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.
Marcin Wasowicz, MD principal investigator
Toronto General Hospital, University Health Network
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Isoflurane/sevoflurane and Propofol in people with Cardiac Surgery, run by University Health Network, Toronto 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 2 inclusion and 4 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 12 Feb 2014. 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. 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?
The composite primary end point of the trial will be the development of enzymatic signs of myocardial injury or MI, postoperative low output syndrome, or both. Enzymatic MI will be determined after obtaining serial measurements of troponin. (time frame: Measurements of troponin levels will be after induction of anesthesia (baseline) and at 0, 2, 4, 8, and 24 h after arrival into the ICU.). 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 NCT01151254, which also lists 2 linked publications.
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 12 Feb 2014.