Comparison of Patients' Satisfaction Between Dexmedetomidine and Remimazolam Anesthesia in Patients With Atrial Fibrillation Undergoing Catheter Ablation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 1
- 主要终点
- The satisfaction levels of the patients
研究概览
简要总结
The primary purpose of this study was to investigate whether remimazolam administration for sedation had a positive effect on patients' satisfaction compared to dexmedetomidine administration in patients with atrial fibrillation undergoing catheter ablation.
Atrial fibrillation is a common arrhythmia in clinical practice. Catheter ablation can be used when the cause of atrial fibrillation is in the pulmonary veins. However, the procedure takes 2 to 4 hours, and patients complain of considerable discomfort. Remimazolam has the advantage of having no drug interaction with CYP3A4 and shorter elimination half-life, duration of action, and shorter recovery time than midazolam, a previously used drug. In addition, compared to dexmedetomidine, side effects such as bradycardia and hypotension are expected to be less. In addition, even if unexpected deep sedation is induced, complete reversal using flumazenil is possible, so the risk of re-sedation could be low.
In other words, when remimazolam is used instead of a drug previously used as a sedative in atrial fibrillation patients undergoing catheter ablation, effects such as rapid action and recovery, reduced complications, improved safety, and improved patient satisfaction can be expected. Therefore, this study was designed to confirm the hypothesis that administration of remimazolam would improve satisfaction in patients undergoing catheter ablation compared to dexmedetomidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-79 years, gender not limited
- •Patients undergoing catheter ablation for atrial fibrillation who require monitored anesthetic care (MAC).
- •Patients with an American Society of Anesthesiologists (ASA) physical status classification 1,2,3.
排除标准
- •Patients with an American Society of Anesthesiologists (ASA) physical status classification >
- •Patients with a history of psychiatric disorders
- •Patients with myocardial infarction or stroke within the past year
- •Patients with a history of major vascular surgery or cardiac surgery within the past year
- •Patients with reduced liver function, chronic kidney disease (stage 3 or higher)
- •Patients diagnosed with heart failure with a left ventricular ejection fraction <40%
- •Patients who need vasopressor or oxygen therapy due to unstable vital signs before procedure.
- •Patients with fever (>38°) or severe uncontrolled high blood pressure
- •Patients with a history of drug hypersensitivity during previous anesthesia
- •Patients who are unable to communicate and have cognitive impairment
- •Patients with a history of drug or alcohol addiction
- •Patients with a history of obstructive sleep apnea
研究组 & 干预措施
remimazolam-remifentanil (RR group)
干预措施: remimazolam-remifentanil (Drug)
dexmedetomidine-remifentanil (DR group)
干预措施: dexmedetomidine-remifentanil (Drug)
结局指标
主要结局
The satisfaction levels of the patients
时间窗: Immediately after the procedure
The satisfaction levels of the patients was assessed with a 5-point numerical scale (0=extremely dissatisfied, 1=dissatisfied, 2=neutral, 3=satisfied, and 4=extremely satisfied).
次要结局
未报告次要终点