Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-
Sympathetic activity could be increased during robot-assisted laparoscopic radical prostatectomy, which is performed in a steep trendelenburg position under CO2 pneumoperitoneum.
Stimulation of the sympathetic nervous system prolongs the QT interval and can increases the susceptibility to life threatening cardiac arrhythmias.
Dexmedetomidine has sympatholytic effects and potential antiarrhythmic properties. Perioperative administration of dexmedetomidine is a potential preventive and treatment strategy for tachyarrhythmia. Thus the investigators decided to evaluate the effect of dexmedetomidine on heart-rate corrected QT interval during robot-assisted laparoscopic radical prostatectomy. Furthermore, the investigators evaluated the Tp-e, Tp-e/QT ratio and Tp-e/QTc ratio as well.
研究概览
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Seoul、大韩民国、03722
- Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institue, Yonsei Universiy College of Medicine
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参与标准
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- ASA class I-II
- Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy
Exclusion Criteria:
- Emergency operation
- Cardiac disease (unstable angina, congestive heart failure, valvular heart disease)
- Ventricular conduction abnormality
- Prior pacemaker insertion
- Abnormal electrolyte values
- Patients who take antiarrythmic agent
- Hepatic or renal failure
- Drug hyperactivity
- Neurological or psychiatric illnesses
学习计划
研究是如何设计的?
设计细节
- 主要用途:预防
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:右美托咪定
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Dexmedetomidine infusion (0.3㎍/kg/hr) from anesthetic induction to the end of pneumoperitoneum
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有源比较器:盐水
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Saline infusion during the same time period
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Dexmedetomidine on heart-rate corrected QT(QTc) interval
大体时间:From pre-induciton until 60 min after the end of pneumoperitoneum
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QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum
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From pre-induciton until 60 min after the end of pneumoperitoneum
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合作者和调查者
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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