Comparison of Remimazolam With Flumazenil vs. Propofol TIVA During RFCA for Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 1
- 主要终点
- Time to eye opening
研究概览
简要总结
This prospective randomized trial aims to compare recovery time from discontinuation of remimazolam followed by flumazenil administration vs. propofol total intravenous anesthesia as the main general anesthetics during radiofrequency catheter ablation treatment of atrial fibrillation.
详细描述
Adult patients with atrial fibrillation undergoing radiofrequency catheter ablation under general anesthesia are randomized to receive either remimazolam with flumazenil or propofol total intravenous anesthesia as the main anesthetics. After completion of radiofrequency ablation, each anesthetic is discontinued. The primary outcome of the study is comparison of the time to the first eye opening responding to doctor's command from the discontinuation of each drug between the groups. Secondary outcomes includes the time to removal of supraglottic laryngeal mask airway device from discontinuation of each drug, incidence of three consecutive hypotension (systolic blood pressure under 80 mmHg) recordings at 2.5 min-intervals, and intraprocedural vasoactive-inotropic score.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patient, age 20-75 years, scheduled for radiofrequency catheter ablation of atrial fibrillation under general anesthesia
排除标准
- •Patients who are not alert before procedure
- •Hemodynamicaly unstable patients before procedure
- •Patients with history of adverse reaction of allergic reaction to study drugs
- •Patients who are anticipated to be unable to remove supraglottic airway or endotracheal tube due to severe dyspnea or need for mechanical ventilatory support
- •Use of sedatives (anxiolytics, psychoactive medication, antidepressants, hypnotics) within 24 h
- •Known galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
- •Severe hepatic or renal dysfunction
- •Alcohol or drug dependence
- •Organic brain disorder
- •Spinal or cerebellar ataxia
- •Acute narrow-angle glaucoma
- •Patients with shock or coma
- •Pregnant or lactating women
- •Patients with hypersensitive to beans or peanut
- •Patients who refuse to participate
研究组 & 干预措施
Remimazolam with flumazenil
Patients allocated to remimazolam with flumazenil group receives remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
干预措施: Remimazolam Besylate (Drug)
Remimazolam with flumazenil
Patients allocated to remimazolam with flumazenil group receives remimazolam as the main anesthetics during general anesthesia and then flumazenil administration at the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
干预措施: Flumazenil (Drug)
Propofol total intravenous anesthesia
Patients allocated to propofol total intravenous anesthesia group receives propofol as the main anesthetics during general anesthesia until the end of anesthesia. Remifentanil continuous infusion can be used for hemodynamic stability and analgesia.
干预措施: Propofol (Drug)
结局指标
主要结局
Time to eye opening
时间窗: up to 1 hour
Time to first eye opening responding to doctor's command from discontinuation of main anesthetics
次要结局
- Incidence of hypotension(During anesthesia for radiofrequency ablation procedure)
- Vasoactive-inotropic score(During anesthesia for radiofrequency ablation procedure)
- Time to remove laryngeal mask airway(up to 1 hour)
研究者
Yunseok Jeon
Professor
Seoul National University Hospital