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

Non Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00336401
• Other study ID #: UHN REB 05-0011-B
• Status: Completed
• Phase: Phase 4
• First received: June 8, 2006
• Last updated: July 29, 2010
• Start date: October 2006
• Est. completion date: February 2008

Study information

• Verified date: September 2006
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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. -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind

Related Conditions & MeSH terms

• Non Cardiac Surgery

Intervention

Drug:
• Sevoflurane or Propofol

Locations

Country	Name	City	State
Canada	Toronto General Hospital, University Health Network	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada,