Effects of Dexmedetomidine on Cardiac Electrophysiology in Patients Under General Anesthesia During Perioperative Period
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB
研究概览
简要总结
Perioperative stress may increase the incidence of adverse events in the cardiovascular system and lead to poor prognosis. Dexmedetomidine is a highly selective α2 adrenergic receptor agonist, which can inhibit stress response and reduce hemodynamic fluctuations. In different usage plans, dexmedetomidine can have different effects on hemodynamics, myocardial electrical activity, cardiac function. The main purpose was to observe its effects on myocardial electrophysiology and cardiac function during perioperative period. The secondary purpose was to explore the optimal dose of dexmedetomidine that has the least adverse effects on perioperative electrocardia action and cardiac function
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ages ranged from 18 to 65
- •ASA I~II
- •patients undergoing elective general anesthesia
- •the surgery time for 1~3 h
排除标准
- •Preoperative ECG abnormalities, including QTc ≥440 ms (male), 460ms (female)
- •abnormal cardiac conduction, prolonged QT syndrome
- •heart disease history, such as pacemaker implantation, unstable angina, congestive heart failure, Heart valve disease
- •antiarrhythmic drugs (β-receptor blockers, calcium channel blockers, tricyclic antidepressants, etc.) that can prolong the QT interval taken within one week before surgery
- •coronary heart disease, non-sinus Heart rhythm, bradycardia, tachycardia, other arrhythmia, etc
- •intraoperative HR≤45 beats/min and need drugs to increase heart rate
- •previous allergy to dexmedetomidine
- •preoperative electrolyte abnormalities
- •emergency surgery, neurological or mental disorders , Liver and kidney dysfunction
- •patients who use analgesic pumps after surgery
- •refusal of patients
研究组 & 干预措施
Loading dose with 0.5 μg/kg, maintenance dose with 0.5 μg/kg
10 min before induction of anesthesia,the loading dose of dexmedetomidine is 0.5 μg/kg, and completed in 10 minutes. The maintenance dose is 0.5 μg/kg per hour during the operation until 0.5 h before the operation finished.
干预措施: Dexmedetomidine (Drug)
Loading dose with 1 μg/kg, maintenance dose with 0.5 μg/kg
10 min before induction of anesthesia,the loading dose of dexmedetomidine is 1 μg/kg, and completed in 10 minutes. The maintenance dose is 0.5 μg/kg per hour during the operation until 0.5 h before the surgery finished.
干预措施: Dexmedetomidine (Drug)
Loading dose with 1 μg/kg, maintenance dose with 1 μg/kg
10 min before induction of anesthesia,the loading dose of dexmedetomidine is 1 μg/kg, and completed in 10 minutes. The maintenance dose is 1 μg/kg per hour during the operation until 0.5 h before the surgery finished.
干预措施: Dexmedetomidine (Drug)
Normal saline
干预措施: Normal saline (Drug)
结局指标
主要结局
The length of PR,QRS,QTc,QT and Tp-e intervals and the level of iCEB
时间窗: during surgery to 1 month after the surgery
All the outcomes above should be measured at the time preparing to pump a loading dose,the time after the loading dose finished,at the end of surgery,1h after the surgery finished,24 h after the surgery finished,48 h after the surgery finished,72 h after the surgery finished,1 month after the surgery finished
次要结局
- The level of systemic vascular resistance(Perioperative)
- The dosage of propofol and remifentanil(intraoperative)
- The level of cardiac circulation efficiency(Perioperative)
- The level of maximum pressure gradient(Perioperative)
- The level of Na+,iCa2+(perioperative)
- The time of eyes opening from surgery ending,the whole surgery,anesthesia(intraoperative)
- The level of heart rate(Perioperative)
- The level of mean arterial blood pressure(Perioperative)
- Total fluid intake from entering the operating room to exiting the PACU(Perioperative)
研究者
Zhuan Zhang
Principal Investigator
Yangzhou University