Comparaison de l’isoflurane et du sévoflurane en chirurgie cardiaque: une étude randomisée d’efficacité comparative et de non-infériorité

Translated title of the contribution: Comparison of isoflurane and sevoflurane in cardiac surgery: a randomized non-inferiority comparative effectiveness trial

Philip M. Jones, Daniel Bainbridge, Michael W.A. Chu, Philip S. Fernandes, Stephanie A. Fox, Ivan Iglesias, Bob Kiaii, Ronit Lavi, John M. Murkin

Research output: Contribution to journalArticlepeer-review

15 Scopus citations

Abstract

Purpose: Volatile anesthetics possess cardioprotective properties, but it is unknown if the cardioprotective effects extend equally to all members of the class. Although sevoflurane is a relatively newer anesthetic than isoflurane, its introduction into practice was not preceded by a head-to-head comparison with isoflurane in a trial focusing on clinically important outcomes. Our objective was to determine whether sevoflurane was non-inferior to isoflurane on a clinically important primary outcome in a heterogeneous group of adults undergoing cardiac surgery. Methods: This was a pragmatic randomized non-inferiority comparative effectiveness clinical trial in 464 adults having coronary artery bypass graft and/or single valve surgery during November 2011 to March 2014. The intervention was maintenance of anesthesia with sevoflurane (n = 231) or isoflurane (n = 233) administered at a dose of 0.5-2.0 MAC throughout the entire operation. All caregivers were blinded except for the anesthesiologist and perfusionist. The primary outcome was a composite of intensive care unit (ICU) length of stay ≥ 48 hr and all-cause 30-day mortality. We hypothesized that sevoflurane would be non-inferior to isoflurane (non-inferiority margin < 10% based on an expected event rate of 25%). Secondary outcomes included prolonged ICU stay, 30- and 365-day all-cause mortality, inotrope or vasopressor usage, new-onset hemodialysis or atrial fibrillation, stroke, and readmission to the ICU. Results: No losses to follow-up occurred. The primary outcome occurred in 25% of sevoflurane patients and 30% of isoflurane patients (absolute difference, −5.4%; one-sided 95% confidence interval, 1.4), thus non-inferiority was declared. Sevoflurane was not superior to isoflurane for the primary outcome (P = 0.21) or for any secondary outcomes. Conclusion: Sevoflurane is non-inferior to isoflurane on a composite outcome of prolonged ICU stay and all-cause 30-day mortality. Sevoflurane is not superior to isoflurane on any other of the clinically important outcomes. This trial was registered at clinicaltrials.gov; NCT01477151.

Translated title of the contributionComparison of isoflurane and sevoflurane in cardiac surgery: a randomized non-inferiority comparative effectiveness trial
Original languageFrench
Pages (from-to)1128-1139
Number of pages12
JournalCanadian Journal of Anesthesia
Volume63
Issue number10
DOIs
StatePublished - Oct 1 2016
Externally publishedYes

ASJC Scopus subject areas

  • Anesthesiology and Pain Medicine

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