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临床试验/NCT02136979
NCT02136979已完成4 期

Effect of Propofol and Sevoflurane on Serum CD39 and CD73 Level After Open Heart Surgery With Cardiopulmonary Bypass

Konkuk University Medical Center1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2014年5月21日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
2
试验地点
1
主要终点
The level of CD39 and CD73 between propofol and sevoflurane group after CPB

研究概览

简要总结

CD39 and CD73 was known protein expressed on surface of Th1 and Th17 cell and modulate immune related reaction. Cardiopulmonary bypass (CPB) can induce inflammatory reaction during cardiac surgery, and induce immunosuppression. Propofol and volatile anesthetics were related to immune reaction. However, the effect of propofol and sevoflurane on the change of CD39 and CD73 after CPB was not evaluated in previous studies.

The authors hypothesized that the expression of CD39 and CD73 would differ between propofol- and volatile anaesthetic-based anaesthesia in patients undergoing CPB. Therefore, the present study determined the effect of propofol and sevoflurane on CD39 and CD73 during and after CPB.

详细描述

After obtaining permission of the Institutional Review Board of Konkuk University Medical Center, Seoul, South Korea , patients scheduled to undergo elective cardiac surgery under cardiopulmonary bypass (CPB) after signed written informed consent agreements and prospectively participate in the present study.

All patients got a cardiac surgery under moderate hypothermic cardiopulmonary bypass (CPB) by one cardiac surgeon. Also, 6ml of blood and sample was obtained for total 5 times in consecutive order.

  1. Before operation (pre-CPB1)
  2. 15 minute after successful CPB weaning (post-CPB1)
  3. 3 hrs after CPB weaning (post-CPB2)
  4. 24 hrs after CPB weaning (post-CPB3)
  5. 48 hrs after CPB weaning (post-CPB4)

The following intraoperative exclusion criteria are applied:

  1. Emergency operation that could not obtain pre-CPB1 sample
  2. Patients who have infectious factor before operation
  3. Patients who have immunosuppressive agent for underlying disease before operation
  4. Patients who have history of cancer previously
  5. Patients who are younger than 19 years old

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Basic Science
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
19 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients scheduled to undergo elective cardiac surgery
  • signed written informed consent agreements

排除标准

  • Emergency operation that could not obtain pre-CPB1 sample
  • Patients who have infectious factor before operation
  • Patients who have immunosuppressive agent for underlying disease before operation
  • Patients who have history of cancer previously
  • Patients who are younger than 19 years old

研究组 & 干预措施

Propofol group

Active Comparator

patients with propofol-based anesthesia

干预措施: Propofol (Drug)

Sevoflurane group

Active Comparator

patients with sevoflurane-based anesthesia

干预措施: Sevoflurane (Drug)

结局指标

主要结局

The level of CD39 and CD73 between propofol and sevoflurane group after CPB

时间窗: from preoperative status up to 48 hrs after CPB weaning status

The difference of CD39 and CD73 level between propofol and sevoflurane group

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Seong-Hyop Kim

Professor

Konkuk University Medical Center

研究点 (1)

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