Randomized Isoflurane and Sevoflurane Comparison in Cardiac Surgery

Last updated: June 3, 2015
Sponsor: Lawson Health Research Institute
Overall Status: Completed

Phase

4

Condition

Myocardial Ischemia

Thrombosis

Chest Pain

Treatment

N/A

Clinical Study ID

NCT01477151
16497
  • Ages > 18
  • All Genders

Study Summary

Anesthesia practice in the 21st century is increasingly outcomes-oriented and evidence-based, but there remain significant gaps in our knowledge, even for commonly-encountered clinical situations. Currently, the two most commonly used drugs used for maintenance of anesthesia in cardiac surgical patients are isoflurane and sevoflurane. There is a belief among many cardiac anesthesiologists that sevoflurane is a better cardiac anesthetic than isoflurane, but there is very little data to support this notion. In fact, very little is known about their comparative effects on important patient outcomes because there has not been a large head-to-head prospective randomized clinical trial. This project will supply the data necessary to critically compare the two anesthetics.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Patients must be 18 years or over (There is no upper age limit to enrollment)

  • Eligible procedures are: CABG on-pump or off-pump, single valve repair/replacement, orCABG/single valve combined procedures

Exclusion

Exclusion Criteria:

  • Cardiac surgeries that are not one of the included cases

  • Planned extubation in the operating room

  • Patients refusing blood products (vis à vis blood sampling)

  • Pregnant patients

  • Malignant hyperthermia or documented/stated allergy to potent volatile anestheticagents

Study Design

Total Participants: 464
Study Start date:
November 01, 2011
Estimated Completion Date:
March 31, 2015

Study Description

Current evidence supports the superiority of sevoflurane for myocardial protection during cardiac surgery when compared to total intravenous anesthesia with propofol. However, there is no evidence to suggest that sevoflurane is superior to isoflurane for myocardial protection during cardiac surgery. Sevoflurane may potentially reduce the rate of post-cardiac surgery atrial fibrillation and the time to tracheal extubation compared to isoflurane, but the literature is equivocal on these two important outcomes. Anesthesiologists still frequently use isoflurane for maintenance of cardiac anesthesia, and this is likely because there is substantial uncertainty about whether or not sevoflurane is superior to isoflurane, given the lack of head-to-head RCTs. A large, prospective, pragmatic RCT can ultimately assist clinicians by providing evidence of the non-inferiority (or, possibly the superiority) of one anesthetic compared to the other on important patient outcomes such as ICU length of stay, mortality, renal dysfunction, time to tracheal extubation after cardiac surgery, rates of clinically-important atrial fibrillation, and myocardial damage.

Connect with a study center

  • University Hospital - London Health Sciences Centre

    London, Ontario N6A5A5
    Canada

    Site Not Available

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