NCT03539003已完成不适用
The Comparison of Changes of QTc, Tp-e Interval, and Tp-e/QT Ratio, Tp-e/QTc Ratio on the ECG During Robotic-assisted Laparoscopic Radical Prostatectomy Under Sevoflurane, Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- heart-rate corrected QT(QTc) interval
研究概览
简要总结
The purpose of this study is to compare the changes of QTc, Tp-e interval, and Tp-e/QT ratio, Tp-e/QTc ratio on the ECG during robotic-assisted laparoscopic radical prostatectomy under sevoflurane, desflurane and total intravenous anesthesia
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA class I-III
- •patients undergoing elective robot-assisted laparoscopic radical prostatectomy
- •adult (≥19 years old)
排除标准
- •emergency surgery
- •preoperative QTc prolongation
- •Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
- •uncontrolled hypertension (DBP >110 mmHg)
- •Patients who take beta blocker
- •Ventricular conduction abnormality
- •Hepatic or renal failure
- •Drug hyperactivity
- •patients unable to understand informed consent (foreigner, illiteracy..)
研究组 & 干预措施
sevoflurane (Group S)
Experimental
general anesthesia with sevoflurane
干预措施: sevoflurane (Drug)
desflurane (Group D)
Active Comparator
general anesthesia with desflurane
干预措施: desflurane (Drug)
total intravenous anesthesia (Group T)
Active Comparator
general anesthesia with total intravenous anesthesia
干预措施: propofol and remifentanil (Drug)
结局指标
主要结局
heart-rate corrected QT(QTc) interval
时间窗: participants will be followed for the duration of surgery, an expected average of 4 hours.
QTc intervals (msec) are recorded from ECG
次要结局
- Tp-e/QTc ratio(Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8))
- Tp-e interval(Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8))
- Heart rate(Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8))
- blood pressure(Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8))
- Tp-e/QT ratio(Baseline (T0), 10 min after induction (T1), 5, 15, 30, 45, 60 min after Trendelenburg position (T2-6), 5 min after desufflation and resuming the supine position (T7), end of surgery (T8))
研究者
研究点 (1)
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