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

Article Article scientifique Article Personalised perioperative dosing of ivabradine in noncardiac surgery : a single-centre, randomised, placebo-controlled, double-blind feasibility pilot trial eng 2024-07-02 2024-10 author White Jamie Marion Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. 963492 author Zaccaria Isabelle Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. author Ennahdi-Elidrissi Florence Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. author Putzu Alessandro 0000-0002-4943-450X Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. 989819 author Dimassi Saoussen Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. 736259 author Luise Stéphane Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. author Daniels John Yaakov 0009-0008-9463-8852 Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. 922101 Département d'anesthésiologie, pharmacologie et soins intensifs (APSIC) John Martin Diaper John Diaper author Mulin Stéphanie Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. author Baudat Aurélie-Djamila Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. 789252 author Gil-Wey Béatrice Margrith Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland. 675152 author Elia Nadia 0000-0003-1787-9288 Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland; Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Faculty of Medicine, University of Geneva, Geneva, Switzerland. 87569 Département d'anesthésiologie, pharmacologie et soins intensifs (APSIC) author Walder Bernhard Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland; Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Faculty of Medicine, University of Geneva, Geneva, Switzerland. 124875 author Bollen Pinto Bernardo 0000-0002-1281-543X Division of Anaesthesiology, Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Geneva University Hospitals, Geneva, Switzerland; Department of Anaesthesiology, Pharmacology, Intensive Care and Emergency Medicine, Faculty of Medicine, University of Geneva, Geneva, Switzerland. Electronic address: bernardo.bollenpinto@hug.ch. 830219 Département d'anesthésiologie, pharmacologie et soins intensifs (APSIC) 738-747 10.1016/j.bja.2024.05.020 38960832 0007-0912 https://www.sciencedirect.com/science/article/pii/S0007091224003167 Background: Perioperative 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. Methods: This 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. Results: Between 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. Conclusions: This 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. Feasibility Ivabradine Perioperative complication Perioperative myocardial injury Pilot study Troponin Dewey 617 63 Département d'anesthésiologie, pharmacologie, soins intensifs et urgences 229 false c65ba1f8-e38c-47fb-b340-4304083b39cd Laboratory of perioperative experimental pathology British journal of anaesthesia 133 4 dbd3b0fa-c38e-4c41-82ba-cac84b1f8360 Article (Published version) Public PIIS0007091224003167.pdf 405382 application/pdf CC BY-4.0 7e66a1aa5e10108dd7557ad4fe30c27a2d07ac5b1f84db0a01fb5c076456e2c1 29b4853f-218b-4403-8733-a996e5d6e49d Supplemental data Public 1-s2.0-S0007091224003167-mmc1.docx 12791 application/vnd.openxmlformats-officedocument.wordprocessingml.document da3ca5f443be18277584d7a605dafb95e892916e5e61fe710c3eafb72521e330 240dcaee-344d-4951-a1f0-efeec748a8c3 Supplemental data Public 1-s2.0-S0007091224003167-mmc2.docx 2010803 application/vnd.openxmlformats-officedocument.wordprocessingml.document baef795340bc4e8a166dc19e2abf35917a8bafb9571f2f60639abcd35b581c8b openAccess Faculté de médecine / Section de médecine clinique / Département d'anesthésiologie, pharmacologie, soins intensifs et urgences

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White, Jamie Marion