Effects of Dexmedetomidine on Respiratory Function and Inflammatory Responses in Patient With Sepsis Undergoing Cleaning Focus of Infection
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The Oxygenation Index
研究概览
简要总结
The purpose of this study is to assess the efficacy of dexmedetomidine on lung protection in patient with sepsis undergoing cleaning focus of infection.
详细描述
Sepsis is one of the most common, life-threatening medical conditions and is frequently complicated by organ failures, especially lung injury. It is well accepted that inflammatory reaction is the major cause of lung injury. Dexmedetomidine (Dex) is a novel α2-adrenoceptor agonist that is primarily used in surgical anesthesia and conscious-sedation. Recently, animal studies have shown that Dex plays an anti-inflammatory role, while it is not known whether Dex possesses any lung protective functions in patients with sepsis. Therefore, the aim of this study is to investigate the efficacy of Dex on lung protection in patient with sepsis undergoing cleaning focus of infection.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients with sepsis requiring abdominal cleaning focus of infection
- •older than 18 years
- •American Society of Anesthesiologists (ASA) physical status II-IV.
排除标准
- •Bradycardia
- •Atrioventricular block
- •Allergic to the drugs
- •A history of respiratory disease
- •Pregnancy or breast-feeding women
研究组 & 干预措施
Dexmedetomidine
25 patients receive a loading infusion of dexmedetomidine (1ug/kg) for 10min follow by a maintenance infusion (0.5ug/kg·h) continued until the end of the surgery
干预措施: dexmedetomidine (Drug)
Placebo
25 patients receive matching placebo （normal saline）
干预措施: normal saline (Other)
结局指标
主要结局
The Oxygenation Index
时间窗: At 3 minutes after the skin is sutured
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the oxygenation index by using blood gas analyzer.
The Alveolar-Arterial Oxygen Difference
时间窗: At 3 minutes after the skin is sutured
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the alveolar-arterial oxygen difference by using blood gas analyzer.
The Respiratory Index
时间窗: At 3 minutes after the skin is sutured
Arterial blood samples were sampled at 3 minutes after the skin is sutured for the respiratory index by using blood gas analyzer.
次要结局
- Change of interleukin-1β before anesthesia and after dexmedetomidine or placebo infusion instantly(Before anesthesia and at 3 minutes after the skin is sutured)
- Change of the lactic acid before anesthesia and after dexmedetomidine or placebo infusion instantly(Before anesthesia and at 3 minutes after the skin is sutured)
- Change of tumor necrosis factor-α before anesthesia and after dexmedetomidine or placebo infusion instantly(Before anesthesia and at 3 minutes after the skin is sutured)