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临床试验/NCT03864276
NCT03864276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 Living Donor Liver Transplantation Under Desflurane and Total Intravenous Anesthesia -Randomized Controlled Trial

Yonsei University1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2019年2月17日最近更新:
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
120
试验地点
1
主要终点
QTc interval

研究概览

简要总结

Prolonged corrected QT interval (QTc) has been observed in about half of patients with liver cirrhosis. Marked prolongation of QTc (ie, 500 msec) has been considered to be a risk factor for fatal ventricular arrhythmia, such as torsade de pointes,7,8 which has been reported in liver transplantation (LT) surgery. In a previous study, prolonged QTc interval ( 500 msec) was frequently observed throughout the procedure of LT, even among patients with baseline QTc 440 msec. Therefore, it is important to optimize electrolyte balance and hemodynamic status to reduce greater risk of perioperative arrhythmias.

The investigators hypothesized that the change of QTc interval might be differ according to method of general anesthesia (inhalation agent vs. intravenous agent).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Triple (Participant, Investigator, Outcomes Assessor)

盲法说明

patients will be randomly allocated to 2 groups using computer-generated randomization method. Care provider will not be blinded to the group allocation, because anesthesiologists should be aware of the method of anesthesia.

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients with liver cirrhosis who will undergo planned liver transplantation

排除标准

  • emergent liver transplantation
  • unstable angina
  • recent MI(Myocardial Infarction)
  • uncontrolled hypertension (diastolic BP > 110mmHg)
  • implantable cardiac defibrillator
  • severe obesity (BMI>30kg/m2)
  • allergy to propofol

研究组 & 干预措施

inhalation anesthesia (desflurane) group

Experimental

Anesthesia is induced and maintained with desflurane and sufentanil

干预措施: inhalation (desflurane) group (Drug)

Total intravenous anesthesia (propofol) group

Experimental

Anesthesia is induced and maintained with propofol and sufentanil

干预措施: total intravenous (propofol) anesthesia (Drug)

结局指标

主要结局

QTc interval

时间窗: 3 minutes after liver reperfusion

The investigator will assess the QTc interval 3 minutes after the reperfusion during liver transplantation.

次要结局

  • QTc interval(at the end of the surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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