Non Cardiac SurgeryPhase 4NCT00336401
Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery
A Phase 4 study testing Sevoflurane or Propofol in people with Non Cardiac Surgery, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Non-cardiac surgery is associated with significant cardiac morbidity and mortality. Volatile anesthetics have a cardioprotective effects which results in preservation of left ventricular function and lower troponin I levels. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Non Cardiac Surgery
- What is being tested?
- Sevoflurane or Propofol
- How many people
- Not given
- Where
- 1 siteCanada
- Study dates
- Oct 2006to Feb 2008
- Phase
- Phase 4
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient undergoing non-cardiac surgery is eligible if s/he: 1.) is ≥45 years old;2.) Has an expected length of stay ≥48 hours; AND3.) Fulfills any 2 of the six criteria for high cardiac risk as defined by the revised Cardiac Risk Index.(see details in protocol)4.) Informed consent
- Exclusion criteria:A patient will be ineligible for this study if s/he:1) Prior adverse reaction to sevoflurane (MH patient) or propofol.2) Previous coronary artery bypass graft (CABG) surgery with complete revascularization in the preceding five years with no evidence of cardiac ischemia since the procedure; or3) Has concomitant life-threatening disease likely to limit life expectancy to <30 days. -
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Toronto General Hospital, University Health Network
Toronto, Ontario, M5G 2C4
About this study
Non-cardiac surgery is associated with significant cardiac morbidity and mortality. Volatile anesthetics have a cardioprotective effects which results in preservation of left ventricular function and lower troponin I levels. Lower troponin release has been correlated with better long term event free survival in both cardiac and non cardiac surgery. A recently completed meta-analysis suggests that sevoflurane is a superior volatile agent. The evidence of a cardioprotective effect in non-cardiac surgery is lacking. Base on the current literature, we intend to evaluate the protective potential of sevoflurane versus propofol anesthesia in high risk patients undergoing elective non-cardiac procedures.
Hypothesis: The use of Sevoflurane as a general anesthetic reduces postoperative troponin release, the incidence of myocardial infarction and/or long term morbidity in patients at low to moderate risk of postoperative cardiac complications, who are undergoing noncardiac surgery.
- Conditions
- Non Cardiac Surgery
- Being tested
- Sevoflurane or Propofol
- Keywords
- anesthesia, non cardiac surgery, cardiac outcomes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sevoflurane or PropofolDrug
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2006 (estimated)
- Study startOct 2006
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non 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 4
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Scott Beattie, MD, PhD, Principal investigator, Toronto General Hospital, University Health Network
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00336401
- Sponsor's protocol ID
- UHN REB 05-0011-B
- Status last verified
- Sep 2006
- First submitted
- 8 Jun 2006
- Last updated
- 30 Jul 2010
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery
- ClinicalTrials.gov ID
- NCT00336401
- Acronym / sponsor ID
- UHN REB 05-0011-B
- Conditions
- Non Cardiac Surgery
- Keywords
- anesthesia, non cardiac surgery, cardiac outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Oct 2006
- Study completion
- Feb 2008 (actual)
- First posted
- 13 Jun 2006 (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.
Non-cardiac surgery is associated with significant cardiac morbidity and mortality. Volatile anesthetics have a cardioprotective effects which results in preservation of left ventricular function and lower troponin I levels. Lower troponin release has been correlated with better long term event free survival in both cardiac and non cardiac surgery. A recently completed meta-analysis suggests that sevoflurane is a superior volatile agent. The evidence of a cardioprotective effect in non-cardiac surgery is lacking. Base on the current literature, we intend to evaluate the protective potential of sevoflurane versus propofol anesthesia in high risk patients undergoing elective non-cardiac procedures.
Hypothesis: The use of Sevoflurane as a general anesthetic reduces postoperative troponin release, the incidence of myocardial infarction and/or long term morbidity in patients at low to moderate risk of postoperative cardiac complications, who are undergoing noncardiac surgery.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Any patient undergoing non-cardiac surgery is eligible if s/he: 1.) is ≥45 years old;2.) Has an expected length of stay ≥48 hours; AND3.) Fulfills any 2 of the six criteria for high cardiac risk as defined by the revised Cardiac Risk Index.(see details in protocol)4.) Informed consent
- Exclusion criteria:A patient will be ineligible for this study if s/he:1) Prior adverse reaction to sevoflurane (MH patient) or propofol.2) Previous coronary artery bypass graft (CABG) surgery with complete revascularization in the preceding five years with no evidence of cardiac ischemia since the procedure; or3) Has concomitant life-threatening disease likely to limit life expectancy to <30 days. -
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Sevoflurane or Propofol | Drug | – |
Primary outcome
Not reported in the source record.
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 30 Jul 2010.
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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.
Scott Beattie, MD, PhD 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 Phase 4 study testing Sevoflurane or Propofol in people with Non 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 0 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 30 Jul 2010. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 30 Jul 2010.