Perioperative medicine & outcomes

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

Br J AnaesthPublished Randomised controlled trial

Authors' conclusion

This pilot study demonstrates the feasibility of, and provides guidance for, a future trial testing the efficacy of personalised perioperative ivabradine.

Study context

Population
Patients ≥75 yr or ≥45 yr with cardiovascular risk factors planned for intermediate- or high-risk noncardiac surgery
Participants
78 patients
Comparison
Personalised HR-targeted perioperative ivabradine vs placebo
Primary endpoint
Appropriate dosage and blinding success rates
Methodological detailsfeasibility pilot, single-centre, placebo-controlled, double-blind, parallel group, Geneva University Hospitals, October 2020 to January 2022
  • Feasibility pilot
  • Single-centre
  • Placebo-controlled
  • Double-blind
  • Parallel group
  • Geneva University Hospitals, October 2020 to January 2022

Primary result

As reported in the abstract

Appropriate dosage rate (439 of 444 study drug administrations adequate)

99%

Blinding success rate

100%

Further findings

Recruitment rate

Recruitment rate (patients week-1)
1.3

Administrations of Pill A (placebo in both groups for HR ≤70 beats min-1)

Pill A administrations, 137
31%

High-sensitive cardiac troponin T elevation ≥14 ng L-1 between any two measurements

Patients with troponin elevation, 9
11.5%

Safety

Events

OutcomeIvabradinePlacebo
Bradycardia episodes98

Original publication

Personalised perioperative dosing of ivabradine in noncardiac surgery: a single-centre, randomised, placebo-controlled, double-blind feasibility pilot trial. Br J Anaesth. Published 2 July 2024. doi:10.1016/j.bja.2024.05.020

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