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

NCT ID: NCT00336401

Last Updated: 2010-07-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2008-02-29

Brief Summary

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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.

Detailed Description

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Conditions

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Non Cardiac Surgery

Keywords

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anesthesia non cardiac surgery cardiac outcomes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

SINGLE

Interventions

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Sevoflurane or Propofol

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Toronto General Hospital, University Health Network

Principal Investigators

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Scott Beattie, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Toronto General Hospital, University Health Network

Locations

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Toronto General Hospital, University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN REB 05-0011-B

Identifier Type: -

Identifier Source: org_study_id