瑞马唑仑甲苯磺酸盐与依托咪酯对瓣膜置换术患者血流动力学影响的随机对照研究方案。

Effect of remimazolam tosilate versus etomidate on hemodynamics in patients undergoing valve replacement surgery: study protocol for a randomized controlled trial.

机构信息

Department of Anesthesiology, The Affiliated Hospital of Guizhou Medical University, 28 Guiyi Rd, Guiyang, Guizhou Province, 550004, People's Republic of China.

Department of Cardiology, The Affiliated Hospital of Guizhou Medical University, 28 Guiyi Rd, Guiyang, Guizhou Province, 550004, People's Republic of China.

出版信息

Trials. 2022 Dec 12;23(1):992. doi: 10.1186/s13063-022-06962-x.

DOI:10.1186/s13063-022-06962-x

PMID:36503508

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC9743663/

Abstract

BACKGROUND

Patients with a history of cardiac disease are prone to develop cardiovascular adverse events such as hypotension, hypertension, and tachycardia during anesthesia induction. Therefore, hemodynamic stability is one of the most important concerns for induction of anesthesia in patients undergoing cardiac surgery. Remimazolam tosilate is a new, ultra-short-acting benzodiazepine agent, with the advantages of rapid onset, rapid offset, and minimal cardiorespiratory depression. We aim to compare the effect of remimazolam tosilate and etomidate on hemodynamics during anesthesia induction in patients undergoing valve replacement surgery.

METHODS/DESIGN: The trial is a prospective, randomized, double-blinded, controlled, single-center trial to compare the effect of remimazolam tosilate and etomidate on hemodynamics in patients undergoing valve replacement surgery. One hundred seventeen patients undergoing selective valve replacement surgery between January 1, 2022, and December 31, 2023, will be enrolled and randomly allocated into one of three groups: low-dose remimazolam group (Group LR), high-dose remimazolam group (Group HR), or etomidate group (Group E). The primary outcome is hemodynamic fluctuations during anesthesia induction (the difference between mean arterial pressure [MAP] to baseline, ▴MAP; and the difference between maximum or minimum heart rate [HR] and baseline, ▴HR). Secondary outcomes include the incidence of adverse cardiovascular events (hypotension, severe bradycardia, hypertension, tachycardia, and arrhythmia), the cumulative doses of vasoactive drugs used per patient, incidence and degree of injection pain and myoclonus, blood glucose values, and vital signs at different time points.

DISCUSSION

This research will determine the effectiveness and safety of remimazolam tosilate induction on hemodynamics in patients undergoing valve replacement surgery.

TRIAL REGISTRATION

www.chictr.org .cn identifier ChiCTR2100052535 . Registered on 17th Dec 2021, http://www.chictr.org.cn/ ).

摘要

背景

患有心脏病史的患者在麻醉诱导期间容易发生低血压、高血压和心动过速等心血管不良事件。因此，血流动力学稳定是心脏手术患者麻醉诱导的最重要关注点之一。甲苯磺酸瑞马唑仑是一种新型的超短效苯二氮䓬类药物，具有起效迅速、消除迅速、对心肺抑制作用最小的优点。我们旨在比较甲苯磺酸瑞马唑仑和依托咪酯对行瓣膜置换术患者麻醉诱导期间血流动力学的影响。

方法/设计：该试验是一项前瞻性、随机、双盲、对照、单中心试验，旨在比较甲苯磺酸瑞马唑仑和依托咪酯对行瓣膜置换术患者血流动力学的影响。2022 年 1 月 1 日至 2023 年 12 月 31 日期间，将纳入 117 例行择期瓣膜置换术的患者，并随机分为三组：低剂量甲苯磺酸瑞马唑仑组（LR 组）、高剂量甲苯磺酸瑞马唑仑组（HR 组）或依托咪酯组（E 组）。主要结局是麻醉诱导期间的血流动力学波动（平均动脉压[MAP]与基线的差值，△MAP；以及最大或最小心率[HR]与基线的差值，△HR）。次要结局包括不良心血管事件（低血压、严重心动过缓、高血压、心动过速和心律失常）的发生率、每位患者使用的血管活性药物的累积剂量、注射疼痛和肌阵挛的发生率和程度、血糖值以及不同时间点的生命体征。