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临床试验/NCT02678728
NCT02678728已完成4 期

Effect of Intraoperative Dexmedetomidine on Lung Protection Following Thoracic Aorta Surgery With Hypothermic Circulatory Arrest: a Randomized Clinical Trial

Gangnam Severance Hospital1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2016年2月最近更新:
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
52
试验地点
1
主要终点
Changes of lung oxygenation from baseline to 24 hr after reperfusion

研究概览

简要总结

Dexmedetomidine has been known to protect the lung against inflammation and oxidative stress in diverse clinical settings. The investigators aimed to investigate the lung protective effect of dexmedetomidine in patients undergoing thoracic aortic surgery with hypothermic circulatory arrest, which is associated with systemic inflammatory response, and oxidative stress.

详细描述

Patients will be divided into 2 groups; dexmedetomidine group and control group. Dexmedetomidine group will receive dexmedetomidine during and after thoracic artery surgery. And control group will receive the same amount of normal saline instead. Analyzing patients lung function and serum factors, which indicates the degree of systemic inflammatory responses and oxidative stress, The investigators will investigate the protective effect of dexmedetomidine on lung.

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, Care Provider, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 98 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients undergoing thoracic aorta surgery with hypothermic circulatory arrest, over 20-of age

排除标准

  • Unstable vital sign before surgery
  • Severe pulmonary disease requiring consistent treatment
  • Illiterate
  • Pregnancy

研究组 & 干预措施

Dexmedetomidine

Experimental

1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion until 12hr of aortic cross clamp off

干预措施: Dexmedetomidine (Drug)

Normal saline

Placebo Comparator

IV loading and infusion of same volume of normal saline after induction until 12hr of aortic cross clamp off

干预措施: normal saline (Drug)

结局指标

主要结局

Changes of lung oxygenation from baseline to 24 hr after reperfusion

时间窗: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr

Lung oxygenation will be assessed by arterial blood gas analysis

Changes of lung compliance from baseline to 24 hr after reperfusion

时间窗: after induction of anesthesia / after reperfusion 1hr / after reperfusion 6hr / after reperfusion 12hr / after reperfusion 24hr

Lung compliance will be displayed on the ventilator

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

Young Song

Associate Professor

Gangnam Severance Hospital

研究点 (1)

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