• Br J Anaesth · Oct 2024

    Randomized Controlled Trial

    Personalised perioperative dosing of ivabradine in noncardiac surgery: a single-centre, randomised, placebo-controlled, double-blind feasibility pilot trial.

    • Marion J White, Isabelle Zaccaria, Florence Ennahdi-Elidrissi, Alessandro Putzu, Saoussen Dimassi, Stéphane Luise, John Diaper, Stéphanie Mulin, Aurélie D Baudat, Béatrice Gil-Wey, Nadia Elia, Bernhard Walder, and Bollen PintoBernardoBDivision of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland; Department of Anaesthesiology, Pharmacology, Intensive Care and Emergen.
    • Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland.
    • Br J Anaesth. 2024 Oct 1; 133 (4): 738747738-747.

    BackgroundPerioperative myocardial injury after noncardiac surgery is associated with postoperative mortality. Heart rate (HR) is an independent risk factor for perioperative myocardial injury. In this pilot trial we tested the feasibility of a randomised, placebo-controlled trial of personalised HR-targeted perioperative ivabradine.MethodsThis was a single-centre, randomised, placebo-controlled, double-blind, parallel group, feasibility pilot trial conducted at Geneva University Hospitals. We included patients ≥75 yr old or ≥45 yr old with cardiovascular risk factors planned for intermediate- or high-risk surgery. Patients were randomised to receive ivabradine (2.5, 5.0, or 7.5 mg) or placebo according to their HR, twice daily, from the morning of surgery until postoperative day 2. Primary outcomes were appropriate dosage and blinding success rates.ResultsBetween October 2020 and January 2022, we randomised 78 patients (recruitment rate of 1.3 patients week-1). Some 439 of 444 study drug administrations were adequate (99% appropriate dosage rate). The blinding success rate was 100%. There were 137 (31%) administrations of Pill A (placebo in both groups for HR ≤70 beats min-1). Nine (11.5%) patients had a high-sensitive cardiac troponin T elevation ≥14 ng L-1 between any two measurements. The number of bradycardia episodes was eight in the placebo group and nine in the ivabradine group.ConclusionsThis pilot study demonstrates the feasibility of, and provides guidance for, a future trial testing the efficacy of personalised perioperative ivabradine. Future studies should include patients at higher risk of cardiac complications.Clinical Trial RegistrationNCT04436016.Copyright © 2024 The Authors. Published by Elsevier Ltd.. All rights reserved.

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