NCT04700514招募中不适用
Effect of Anesthetic Drugs on Neurocognitive Function in Children With Retinoblastoma Requiring Multiple Anesthetic Exposure - Preliminary Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Developmental Test
研究概览
简要总结
This study evaluate the effect of dexmedetomidine on intelligence test in pediatric patients with multiple anesthesia exposure. Children who are diagnosed with retinoblastoma and receive first exam under general anesthesia before age of 2 are included. Intelligence test will performed when patients' age are 4.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- — 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are first diagnosed as retinoblastoma and scheduled for EUA and treatment under general anesthesia before age of 2
排除标准
- 未提供
研究组 & 干预措施
Dexmedetomidine group
Experimental
- Children who are diagnosed with retinoblastoma and are scheduled for the first EUA before their age of 30 months.
- No history of anesthesia
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Developmental Test
时间窗: year 4
visual-Motor Integration test
IQ score at age of 4
时间窗: year 4
Korean-Wechsler Preschool and Primary Scale of Intelligence test (score \>131, high; score 116-130, high-normal; socre 85-115, normal; score 70-84; low-normal; score \<69; low)
次要结局
未报告次要终点
研究者
Ji-Hyun Lee
Clinical Associate Professor
Seoul National University Hospital
研究点 (1)
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