Efficacy and Safety of Remimazolam vs. Inhalational Anesthetics for General Anesthesia for the Ablation of Arrhythmia: Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Vasopressor CIV
研究概览
简要总结
In anesthesia for ablation for cardiac arrhythmias, abrupt hemodynamic changes or fatal arrhythmias can be seen frequently. Remimazolam is a novel ultra-short acting benzodiazepine that provides good hemodynamic stability compared to conventional anesthetic agents. This study aims to investigate whether remimazolam reduces vasoactive agent use during cryo/radiofrequancy ablation under general anesthesia, compared to desflurane(RCT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 105 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •=or > 20 years
- •Admission for General anesthesia for RFCA or cryoablation procedure
排除标准
- •No severe adverse effect history or hypersensitivity of benzodiazepines or its additives
- •Acute alcoholic intoxication state
- •Coma or shock state due to other condition than heart problem.
- •Acute narrow-angle glaucoma
研究组 & 干预措施
Remimazolam
General anesthesia with remimazolam-remifentanil TIVA.
干预措施: Remimazolam besylate (Drug)
结局指标
主要结局
Vasopressor CIV
时间窗: During anesthesia
Vasopressor CIV or not
Hypotension event
时间窗: During and after anesthesia
Hypotension event
Vasopressor (total amount)
时间窗: During anesthesia
Norepinephrine equivalent dose
次要结局
- Adverse event(During and after anesthesia (~24hr))
- Induction time(Induction)
- Recovery time(Recovery)
研究者
In-Ae Song
Professor
Seoul National University Bundang Hospital