Effects of Dexmedetomidine on the Liver Injury After Hepatectomy
the Ethnic Committee of the Chinese People's Liberation Army (PLA) General Hospital
研究概览
详细说明
The purpose of our study is to compare liver injury with dexmedetomidine. The enrolled patients were randomized into two group. In the study group, dexmedetomidine, diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1. While, 0.9% sodium chloride serves as the placebo with the same loading dose and infusion rate in the control group. The infusion is ceased after the resection of the hepatic issues.
GST is a sensitive and specific marker for hepatic injury in several studies before and is taken as the primary endpoint. And the investigator use other inflammatory cytokines reflecting the systemic inflammatory response in serum. Besides these, the investigator observe the hemodynamic changes during the operation time and complications related with anesthesia and surgery.
研究类型
注册 (实际的)
阶段
- 第四阶段
联系人和位置
学习地点
-
-
Beijing
-
Beijing、Beijing、中国、100853
- Chinese PLA General Hospital
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- American Society of Anesthesiologists (ASA) I~III
- selected to have hepatectomy in our hospital, Child-Pugh A
- patient's consent
Exclusion Criteria:
- refusing to attend or attending in other clinical study
- having severe cardio-pulmonary disease, ejection fraction (EF)<40%, having cardiac infarction in recent three months, chronic obstructive pulmonary disease (COPD) (PaO2<60mmHg)
- pregnant or lactating women
- having neuropsychiatric disorders
- emergent surgeries，hemorrhage shock，
- rupture and hemorrhage of liver tumor
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：dexmedetomidine
dexmedetomidine 2mg is diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1.
The infusion is ceased after the resection of the hepatic issues.
|
dexmedetomidine 2mg is diluted in 0.9% sodium chloride with the concentration of 4 ug ml-1 is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1.
The infusion is ceased after the resection of the hepatic issues.
|
|
安慰剂比较：0.9% sodium chloride
0.9% sodium chloride is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1.
The infusion is ceased after the resection of the hepatic issues.
|
0.9% sodium chloride is administered with an loading dose of 0.5ug kg-1 of 10 min, and maintained with infusion rate of 0.5 ug kg-1 h-1.
The infusion is ceased after the resection of the hepatic issues.
|
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 |
|---|---|---|
|
GST
大体时间：24 hours
|
baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy 30 minutes after hepatic resection
|
24 hours
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
interleukin (IL-6), tumor necrosis factor (TNF-a)
大体时间：24 hours
|
baseline (before the surgery), 30 minutes after hepatic resection, 1 day after hepatectomy
|
24 hours
|
其他结果措施
结果测量 |
大体时间 |
|---|---|
|
Complications after surgery
大体时间：1 month after surgery
|
1 month after surgery
|
合作者和调查者
调查人员
- 学习椅：Weidong MI, Doctor、China
研究记录日期
研究主要日期
学习开始 (实际的)
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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