Sedation Regimen in Patients Undergoing Cardiac Electrophysiology Study and Ablation : a Comparison Between Dexmedetomidine-remifentanil and Midazolam-remifentanil Combinations
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 主要终点
- change of sedation depth
研究概览
简要总结
Cardiac ablation is an invasive procedure requiring anesthetic support for immobility and analgesia. Benzodiazepines and opioids are the most commonly used agents, while they are associated with respiratory depression and hypotension. The aim of this study was to compare the effect of remifentanil and dexmedetomidine, which exerts sedative and analgesic effect without serious respiratory depression, with conventional midazolam/remifentanil combination on sedative and analgesic levels in patients undergoing endocardial ablation.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective cardiac ablation for atrial fibrillation
排除标准
- •ASA physical status class ≥ 3,
- •respiratory disease,
- •end stage renal disease,
- •illiterate
研究组 & 干预措施
dexmedetomidine-remifentanil
intravenous infusion of 0.2-0.7 µg/kg/h of dexmedetomidine after a loading dose of 1 µg/kg over 10 min
干预措施: dexmedetomidine-remifentanil (Drug)
midazolam-remifentanil
remifentanil 3.6-7.2 mcg/kg/h midazolam 1-2mg
干预措施: midazolam-remifentanil (Drug)
结局指标
主要结局
change of sedation depth
时间窗: 5 min after study drug adminstration, and every 10 min thereafter
1. Ramsay sedation score (1 = anxious and agitated, restless; 2 = cooperative, oriented, tranquil; 3 = responsive to verbal commands, drowsy; 4 = asleep, responsive to light stimulation; 5 = asleep, slow response to stimulation; 6 = no response to stimulation) 2. the bispectral index
次要结局
未报告次要终点