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Remimazolam to prevent hemodynamic instability during catheter ablation under general anesthesia: a randomized controlled trial

Le remimazolam pour prévenir l’instabilité hémodynamique lors de l’ablation par cathéter sous anesthésie générale : une étude randomisée contrôlée

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Abstract

Purpose

Maintaining hemodynamic stability during cardiac ablation under general anesthesia is challenging. Remimazolam, a novel ultrashort-acting benzodiazepine, is characterized by maintaining comparatively stable blood pressure and does not influence the cardiac conduction system, which renders it a reasonable choice for general anesthesia for cardiac ablation. We aimed to evaluate whether remimazolam is associated with a decreased incidence of intraoperative hypotension compared with desflurane.

Methods

In this single-centre, parallel-group, prospective, single-blind, randomized clinical trial, we randomized patients (1:1) into a remimazolam group (remimazolam-based total intravenous anesthesia) or desflurane group (propofol-induced and desflurane-maintained inhalational anesthesia) during cardiac ablation procedures for arrhythmia. The primary outcome was the incidence of intraoperative hypotensive events, defined as mean arterial pressure of < 60 mm Hg at any period.

Results

Overall, we enrolled 96 patients between 2 August 2022 and 19 May 2023 (47 and 49 patients in the remimazolam and desflurane groups, respectively). The remimazolam group showed a significantly lower incidence of hypotensive events (14/47, 30%) than the desflurane group (29/49, 59%; relative risk [RR], 0.5; 95% confidence interval [CI], 0.31 to 0.83; P = 0.004). Remimazolam was associated with a lower requirement for bolus or continuous vasopressor infusion than desflurane was (23/47, 49% vs 43/49, 88%; RR, 0.56; 95% CI, 0.41 to 0.76; P < 0.001). No between-group differences existed in the incidence of perioperative complications such as nausea, vomiting, oxygen desaturation, delayed emergence, or pain.

Conclusions

Remimazolam was a viable option for general anesthesia for cardiac ablation. Remimazolam-based total intravenous anesthesia was associated with significantly fewer hypotensive events and vasopressor requirements than desflurane-based inhalational anesthesia was, without significantly more complications.

Study registration

ClinicalTrials.gov (NCT05486377); first submitted 1 August 2022.

Résumé

Objectif

Le maintien de la stabilité hémodynamique lors d’une ablation cardiaque sous anesthésie générale est un défi. Le remimazolam, une nouvelle benzodiazépine à action ultra-courte, se caractérise par le maintien d’une tension artérielle relativement stable et son absence d’influence sur le système de conduction cardiaque, ce qui en fait un choix raisonnable pour l’anesthésie générale pour l’ablation cardiaque. Nous avons cherché à déterminer si le remimazolam est associé à une diminution de l’incidence d’hypotension peropératoire comparativement au desflurane.

Méthode

Dans cette étude clinique randomisée, prospective, en simple aveugle, en groupes parallèles et monocentrique, nous avons randomisé des patient·es (1:1) dans un groupe remimazolam (anesthésie intraveineuse totale à base de remimazolam) et un groupe desflurane (anesthésie volatile induite par propofol et maintenue par desflurane) pendant des interventions d’ablation cardiaque pour arythmie. Le critère d’évaluation principal était l’incidence d’événements hypotensifs peropératoires, définis comme une tension artérielle moyenne de < 60 mm Hg à n’importe quelle période.

Résultats

Au total, nous avons recruté 96 patient·es entre le 2 août 2022 et le 19 mai 2023 (47 et 49 personnes dans les groupes remimazolam et desflurane, respectivement). Le groupe remimazolam a montré une incidence significativement plus faible d’événements hypotensifs (14/47, 30 %) que le groupe desflurane (29/49, 59 %; risque relatif [RR], 0,5; intervalle de confiance [IC] à 95 %, 0,31 à 0,83; P = 0,004). Le remimazolam a été associé à des besoins plus faibles de bolus ou de perfusion continue de vasopresseurs que le desflurane (23/47, 49 % vs 43/49, 88 %; RR, 0,56; IC 95 %, 0,41 à 0,76; P < 0,001). Il n’y avait pas de différences entre les groupes dans l’incidence des complications périopératoires telles que les nausées, les vomissements, la désaturation en oxygène, l’émergence retardée ou la douleur.

Conclusion

Le remimazolam a constitué une option viable pour l’anesthésie générale en vue d’une ablation cardiaque. L’anesthésie intraveineuse totale à base de remimazolam a été associée à un nombre significativement plus faible d’événements d’hypotension et de besoins en vasopresseurs que l’anesthésie par inhalation à base de desflurane, sans complications significativement plus nombreuses.

Enregistrement de l’étude

ClinicalTrials.gov (NCT05486377); soumis pour la première fois le 1er août 2022.

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Authors and Affiliations

  1. Department of Anesthesiology and Pain Medicine, Seoul National University Bundang Hospital, Seongnam, Republic of Korea

    Subin Yim MD, Insun Park MD, PhD, Bon Wook Koo MD, PhD, Ah Young Oh MD, PhD & In-Ae Song MD, PhD

  2. Department of Anesthesiology and Pain Medicine, Yonsei University College of Medicine, Seoul, Republic of Korea

    Chang Ik Choi MD

  3. Department of Anesthesiology and Pain Medicine, Yongin Severance Hospital, Yongin, Republic of Korea

    Chang Ik Choi MD

  4. Department of Anesthesiology and Pain Medicine, Seoul National University College of Medicine, Seoul, Republic of Korea

    Bon Wook Koo MD, PhD, Ah Young Oh MD, PhD & In-Ae Song MD, PhD

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Author contributions

Subin Yim and In-Ae Song contributed to study design and drafting the manuscript. Subin Yim, Chang Ik Choi, Insun Park, Bon Wook Koo, and Ah Young Oh contributed to data acquisition. In-Ae Song, Chang Ik Choi, Bon Wook Koo, and Insun Park contributed to data analysis. Subin Yim, In-Ae Song, and Ah Young Oh contributed to data interpretation and critical revision of the manuscript. Ah Young Oh aquired funding.

Disclosures

The authors declare no competing interests.

Funding statement

This study was supported by Hana Pharmaceutical, Seoul, Republic of Korea (grant number: 06-2022-0201).

Editorial responsibility

This submission was handled by Dr. Philip M. Jones, Deputy Editor-in-Chief, Canadian Journal of Anesthesia/Journal canadien d’anesthésie.

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Yim, S., Choi, C.I., Park, I. et al. Remimazolam to prevent hemodynamic instability during catheter ablation under general anesthesia: a randomized controlled trial. Can J Anesth/J Can Anesth (2024). https://doi.org/10.1007/s12630-024-02735-z

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