Long-term Effect of General Anesthesia Before School Age on Neurodevelopment in Children With Congenital Scoliosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- full-scale intelligence quotient, FSIQ
研究概览
简要总结
In the past, a large number of animal studies have suggested that anesthesia exposure has potential neurotoxic effects, resulting in persistent cognitive and behavioral deficits. At present, there is still a lack of sufficient clinical research evidence to prove whether anesthesia exposure has long-term effects on neurodevelopment. The existing clinical research data suggests that a single short-time anesthesia exposure in young children does not affect long-term neurodevelopmental outcomes. Early onset scoliosis, including congenital scoliosis, is a type of scoliosis deformity that occurs before the age of 10. Posterior scoliosis correction surgery is one of the common treatment. There is currently no research indicating the impact of early single or multiple long-duration anesthesia exposure on the neurological development of children with congenital scoliosis. The aim of this study is to determine the long-term effect of general anesthesia exposure on neurocognitive function and behavior in children with congenital scoliosis, in order to provide reference for related clinical work.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with congenital scoliosis
- •6-16 years old at the time of assessment
排除标准
- •Cognitive impairment caused by congenital, traumatic or other reasons;
- •Existence of mental or psychological disorders;
- •There are factors that may affect neurological development, including any known central nervous system disease, neurological injury, or history of neonatal asphyxia;
- •Unable to cooperate with cognitive function tests;
- •The child is unable to communicate in Chinese.
结局指标
主要结局
full-scale intelligence quotient, FSIQ
时间窗: At the time of collecting baseline demographic data
Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)
次要结局
- Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI)(At the time of collecting baseline demographic data)
- CBCL Total score, CBCL Internalizing score, CBCL Externalizing score(Within six months of WISC-IV assessment)
- SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior score(Within six months of WISC-IV assessment)
研究者
Lulu Ma
Chief physician, Professor
Peking Union Medical College Hospital