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临床试验/NCT00886275
NCT00886275已完成4 期

Comparing the Effect of Dexmedetomidine With Midazolam on Sedation, Oxidative Stress, and Microcirculation in Intensive Care Unit

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 33 人开始时间: 2010年7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
33
试验地点
1
主要终点
Time to extubation

研究概览

简要总结

In intensive care unit, patients suffered pain and anxiety from mechanical ventilation, presence of endotracheal tube, central venous catheter, postoperative wound, and invasive procedures. Adequate analgesia and sedation can reduce pain and anxiety. However, traditional sedatives carry the risk of unstable hemodynamic status, respiratory depression, increased mechanical ventilation time, incidence of delirium, and length of ICU stay. Dexmedetomidine is a highly selec¬tive α2-adrenergic receptor agonist which causes sedative effects and reduces opioid requirements in the perioperative period. Memis et al had found that dexmedetomidine may prevent inflammatory effects in sepsis patients during sedation. Oxidative stress status is related to the inflammatory response. Moreover, oxidative stress may result in dysfunction of microcirculation. Dysfunction of microcirculation may cause vasoconstriction or microthrombosis, and it will impair tissue perfusion and result in organ dysfunction. The goal of this study is to compare the effects of dexmedetomidine and midazolam on requirement of analgesics, weaning parameter, hemodynamic status, time of extubation, incidence of delirium, and length of ICU stay, oxidative stress status, and microcirculation.

研究设计

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

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient who is older than 18 years old and less than 80 years old
  • Patient who is admitted to intensive care unit with artery line
  • Patient's hemodynamic status is stable under adequate management and absence of signs of shock
  • Patient who has understood the inform consent and agree to participate this study

排除标准

  • Patient's hemodynamic status is unstable in spite of adequate management or presence of signs of shock
  • Patient who has a past history of allergy to study drugs
  • Patient who has renal failure or requires renal replacement therapy
  • Patient who has liver cirrhosis or liver failure
  • Patient who has participated in any other investigational study of other drugs currently
  • Female patient who is pregnant or considers breast feeding currently

研究组 & 干预措施

Dexmedetomidine

Experimental

干预措施: Dexmedetomidine (Drug)

Midazolam

Active Comparator

干预措施: Midazolam (Drug)

Dexmedetomidine, Midazolam

Experimental

Combination

干预措施: Dexmedetomidine, Midazolam (Drug)

结局指标

主要结局

Time to extubation

时间窗: hour

次要结局

  • ICU Stay Weaning parameter(Hour)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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