Effect of Dexmedetomidine on Heart-rate Corrected QT(QTc) Interval Prolongation During Robotic-assisted Laparoscopic Radical Prostatectomy -Randomized Blind Clinical Trial-
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Dexmedetomidine on heart-rate corrected QT(QTc) interval
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •ASA class I-II
- •Otaining written informed consent from the patients who were undergoing robot- assisted laparoscopic radical prostatectomy
排除标准
- •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
研究组 & 干预措施
Dexmedetomidine
干预措施: Dexmedetomidine (Drug)
Saline
干预措施: Saline (Drug)
结局指标
主要结局
Dexmedetomidine on heart-rate corrected QT(QTc) interval
时间窗: From pre-induciton until 60 min after the end of pneumoperitoneum
QTc intervals (msec) are recorded from pre-induction until 60 min after the end of pneumoperitoneum
次要结局
未报告次要终点