The Effects of Dexmedetomidine on the Neurotoxicity From General Anesthesia Assessed by Plasma Glial Fibrillary Acidic Protein
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Glial fibrillary acid protein
研究概览
简要总结
Neuroapoptosis is induced by the administration of anesthetic agents to the young brain. Recent studies showed that the a2-adrenoceptor agonist, dexmedetomidine plays a trophic role during development and is neuroprotective in several settings of neuronal injury in animals. We hypothesized that neuroprotective effect of dexmedetomidine would be associated with evidence of brain injury detected by elevation of plasma concentration of glial fibrillary acid protein in children undergoing general anesthesia.
详细描述
GFAP measure
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Month 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •children undergoing general anesthesia longer than 3 hours
排除标准
- •past history of anesthesia
- •cardiopulmonary bypass
- •preexisting neurocognitive dysfunction
- •abnormalities of liver profile (aspartate transaminase > 40 unit/L, alanine aminotransferase > 40 unit/L)
研究组 & 干预措施
control
placebo infusion
干预措施: control (Other)
Dexmedetomidine
dexmedetomidine infusion
干预措施: Dexmedetomidine Hydrochloride (Drug)
结局指标
主要结局
Glial fibrillary acid protein
时间窗: change from baseline glial fibrillary acid protein at 3 hours after the anesthetic induction
plasma was collected at the given specific time
次要结局
未报告次要终点
研究者
Hee-Soo Kim
Professor
Seoul National University Hospital