比较胺碘酮和艾司洛尔预防心脏瓣膜或主动脉手术患者再灌注性室颤：一项随机对照临床试验的研究方案。

Comparison of amiodarone and esmolol for prevention of reperfusion ventricular fibrillation in individuals undergoing heart valve or aortic surgery: a study protocol for a randomized controlled clinical trial.

机构信息

Department of Anesthesiology, The First Hospital of China Medical University, 155 Nanjing North Street, Heping District, Shenyang City, Liaoning Province, China.

出版信息

Trials. 2023 Nov 27;24(1):758. doi: 10.1186/s13063-023-07816-w.

DOI:10.1186/s13063-023-07816-w

PMID:38012733

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC10680225/

Abstract

BACKGROUND

Amiodarone and esmolol can help to prevent and treat post-cardiac surgery reperfusion ventricular fibrillation. However, the relative efficacies of these two drugs remain unknown. The aim of the current trial is to compare the performances of amiodarone and esmolol for preventing reperfusion ventricular fibrillation following open heart surgery.

METHODS/DESIGN: This is a single-center, prospective, double-blind, controlled clinical trial. A total of 260 patients undergoing heart valve or aortic surgery will be assigned randomly to treatment with prophylactic esmolol (intervention group) or amiodarone (control group). The main outcome is the incidence of reperfusion ventricular fibrillation following aortic opening during extracorporeal circulation. The secondary outcomes are the rate of automatic cardiac resuscitation, energy and frequency of electrical defibrillation, number of electrical defibrillations, and pacemaker use in the two groups of patients. Information on the patients' general condition and the durations of anesthesia, extracorporeal circulation, aortic occlusion, and operation time will be recorded. We will also compare the heart rate, mean arterial pressure, and central venous pressure between the two groups of patients at induction of anesthesia (T1), start of surgery (T2), start of extracorporeal circulation (T3), aortic block (T4), aortic opening (T5), after opening for 10 (T6), 20 (T7), and 30 min (T8), at cessation of extracorporeal circulation (T9), and at the end of surgery (T10) and compare blood gas analysis results at T1, T5, T9, and T10.

DISCUSSION

This study will determine if prophylactic esmolol is more effective than amiodarone for reducing the incidence of reperfusion ventricular fibrillation in patients undergoing heart valve or aortic surgery.

TRIAL REGISTRATION

China Clinical Trials Registry ChiCTR1900026429. Registered on 2019.10.9.

摘要

背景

胺碘酮和艾司洛尔可帮助预防和治疗心脏手术后再灌注性心室颤动。然而，这两种药物的相对疗效尚不清楚。本试验旨在比较胺碘酮和艾司洛尔预防体外循环下心内直视手术后再灌注性心室颤动的效果。

方法/设计：这是一项单中心、前瞻性、双盲、对照临床试验。将 260 例行心脏瓣膜或主动脉手术的患者随机分为预防性使用艾司洛尔（干预组）或胺碘酮（对照组）。主要结局为体外循环主动脉开放后再灌注性心室颤动的发生率。次要结局为两组患者自动心脏复律率、电除颤能量和频率、电除颤次数以及起搏器使用情况。记录患者一般情况以及麻醉、体外循环、主动脉阻断和手术时间。我们还将比较两组患者麻醉诱导时（T1）、手术开始时（T2）、体外循环开始时（T3）、主动脉阻断时（T4）、主动脉开放时（T5）、开放后 10（T6）、20（T7）和 30 分钟（T8）、体外循环停止时（T9）和手术结束时（T10）的心率、平均动脉压和中心静脉压，并比较 T1、T5、T9 和 T10 时的血气分析结果。