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瑞马唑仑预防全麻下导管消融术中心血管不稳定的随机对照试验。

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

机构信息

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

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

出版信息

Can J Anaesth. 2024 Aug;71(8):1067-1077. doi: 10.1007/s12630-024-02735-z. Epub 2024 Apr 12.

DOI:10.1007/s12630-024-02735-z
PMID:38609684
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.

摘要

目的

在全身麻醉下进行心脏消融术时,维持血流动力学稳定具有挑战性。雷米唑仑是一种新型超短效苯二氮䓬类药物,其特点是血压相对稳定,不影响心脏传导系统,因此是心脏消融术全身麻醉的合理选择。我们旨在评估与依托咪酯相比,雷米唑仑是否与术中低血压发生率降低相关。

方法

在这项单中心、平行组、前瞻性、单盲、随机临床试验中,我们将患者(1:1)随机分为雷米唑仑组(雷米唑仑为基础的全静脉麻醉)或依托咪酯诱导和七氟醚维持的吸入麻醉组(依托咪酯组),进行心律失常的心脏消融术。主要结局是术中低血压事件的发生率,定义为任何时间段的平均动脉压<60mmHg。

结果

总体而言,我们于 2022 年 8 月 2 日至 2023 年 5 月 19 日期间纳入了 96 名患者(雷米唑仑组和依托咪酯组各 47 名和 49 名患者)。雷米唑仑组的低血压事件发生率(14/47,30%)明显低于依托咪酯组(29/49,59%;相对风险[RR],0.5;95%置信区间[CI],0.31 至 0.83;P=0.004)。与依托咪酯相比,雷米唑仑需要使用血管加压药推注或持续输注的情况更少(23/47,49% vs 43/49,88%;RR,0.56;95%CI,0.41 至 0.76;P<0.001)。两组在恶心、呕吐、氧饱和度降低、苏醒延迟或疼痛等围手术期并发症的发生率方面无差异。

结论

雷米唑仑是心脏消融术全身麻醉的可行选择。与依托咪酯组相比,雷米唑仑组低血压事件和血管加压药需求明显减少,而并发症无显著增加。

研究注册

ClinicalTrials.gov(NCT05486377);首次提交日期为 2022 年 8 月 1 日。

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