Pharmacokinetic-pharmacodynamic Analysis for Dosing Strategy and Evaluation of Safety and Efficacy of Dexmedetomidine in Children
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 1
- 主要终点
- University of Michigan Sedation Scale
研究概览
简要总结
This study evaluates pharmacokinetics and pharmacodynamics of dexmedetomidine for children under sedation at intensive care unit after surgery. Patients will receive dexmedetomidine intravenously for 50 minutes after surgery as as sedation drug.
详细描述
Dexmedetomidine, an alpha-2 adrenergic agonist, is being effectively used for procedural sedation or sedation at intensive care unit. However, the safety and efficacy profile are not yet established for children. Although there have been some studies regrading it, still there is no public guideline, therefore making it difficult to use dexmedetomidine in children.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 7 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients planned to undergo mechanical ventilation at intensive care unit after surgery
- •Pediatric patients planned to be extubated within 4 hours after surgery for neurological examination
- •Patients whose parent of legal guardian agreed to enroll in the study after having enough time to review the complete explanation about the study.
排除标准
- •History of hypersensitivity to any drugs including dexmedetomidine.
- •Underlying cardiovascular/circulatory disease
- •Underlying liver / kidney disease
- •Patients under hemodialysis
- •Obesity of BMI > 35
- •Patients planned to receive patient-controlled analgesia including opioids
- •Patients whose parent or legal guardian declined to enroll in the study
- •Other conditions deemed unsuitable for the study
研究组 & 干预措施
Dexmedetomidine
Intravenous infusion of dexmedetomidine for 50 min after surgery at intensive care unit
干预措施: Dexmedetomidine Hydrochloride (Drug)
结局指标
主要结局
University of Michigan Sedation Scale
时间窗: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion
University of Michigan Sedation Scale based on observer's inspection during patient's stay at intensive care unit (0-4, higher score implies deeper sedation)
Bispectral index
时间窗: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion
Bispectral index based on electroencephalogram during patient's stay at intensive care unit (0-100, lower score implies deeper sedation)
Plasma concentration of dexmedetomidine
时间窗: From start of dexmedetomidine infusion to 480 minutes after end of dexmedetomidine infusion
Plasma concentration of dexmedetomidine before infusion, 10/30/60 minutes after initiation of infusion, 15/30/60/120/240/480 minutes after end of infusion
次要结局
- Respiratory rate(From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion)
- Incidence of arrhythmia(From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion)
- Non-invasive blood pressure(From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion)
- Incidence of desaturation(From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion)
- Incidence of nausea(From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion)
- Incidence of vomiting(From start of dexmedetomidine infusion to 24 hours after end of dexmedetomidine infusion)
研究者
Hee-Soo Kim
M.D., Ph.D., Professor
Seoul National University Hospital