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临床试验/ChiCTR-OOC-17012631
ChiCTR-OOC-17012631进行中(未招募)不适用

在成年危重病人中使用延長輸注右美托咪定注射液的藥代動力學模型的外部驗證

Department of Anaesthesia and Intensive Care, CUHK1 个研究点 分布在 1 个国家目标入组 23 人开始时间: 1990年1月1日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
23
试验地点
1
主要终点
Dexmedetomidine serum concentrations

研究概览

简要总结

在成年危重病人中使用延長輸注右美托咪定注射液的藥代動力學模型的外部驗證

研究设计

研究类型
观察性研究
主要目的
单臂
盲法
N/a

入排标准

年龄范围
18 至 —(—)
性别
All

入选标准

  • All patients admitted to the Prince of Wales Hospital in Hong Kong expecting to requiring prolonged sedation for more than 24 hours but less than 2 weeks of dexmedetomidine for mechanical ventilation will be included.

排除标准

  • The exclusion criteria will include the following: history of intolerance to dexmedetomidine, use of centrally acting α2-agonsits or antagonists (eg. clonidine), need for continuous muscle relaxation, uncompensated circulatory failure (mean arterial pressure < 55mm Hg despite vasopressors and inotropes), severe bradycardia (heart rate < 50 beats/min), second or third degree atrioventricular block, severe hepatic impairment (bilirubin > 101 μmol/L), acute severe intracranial or spinal neurologic disorder, significant haematological, endocrine, metabolic or gastrointestinal disease, or burn injuries and other injuries requiring regular anaesthesia or surgery.

研究组 & 干预措施

Case series

Dexmedetomidine, intravenous 0.1-0.7 mcg/kg/hr Upto 2 weeks, Continuous infusion.

结局指标

主要结局

Dexmedetomidine serum concentrations

时间窗: At the start of infusion, 0, 2, 4, 7, 10, 15, 20, 30, 40 and 60 min, and then at 2, 3, 4, 6, 12, 18 and 24 hours. If the patient is still receiving the infusion, samples will be taken twice a day. At the end of dexmedetomidine infusion (time = 0 min), and again at 2,

次要结局

  • Sedation score(At the start of the infusion (t = 0), 1, 2, 3, 4, 6, 12, 18, 24 h, then three time daily during infusion. After the end of dexmedetomidine infusion, RASS scores will be measured at 0, 1, 2, 3, 4, 6,12,18, 24 and 36 hours.)

研究者

发起方
Department of Anaesthesia and Intensive Care, CUHK

研究点 (1)

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在成年危重病人中使用延長輸注右美托咪定注射液的藥代動力學模型的外部驗證 | 临床试验