Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery

This study has been completed.
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00336401
First received: June 8, 2006
Last updated: July 29, 2010
Last verified: September 2006

June 8, 2006
July 29, 2010
October 2006
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Complete list of historical versions of study NCT00336401 on ClinicalTrials.gov Archive Site
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Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery
Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery

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.

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Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Non Cardiac Surgery
Drug: Sevoflurane or Propofol
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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February 2008
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Inclusion Criteria:

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. -

Both
45 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00336401
UHN REB 05-0011-B
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Scott Beattie, Toronto General Hospital, University Health Network
University Health Network, Toronto
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Principal Investigator: Scott Beattie, MD, PhD Toronto General Hospital, University Health Network
University Health Network, Toronto
September 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP