Bronchoscopy Anesthesia and Neuropsychological Assessment in Children (BANACH) Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 290
- 主要终点
- The detection rate of abnormal behavior in both groups
研究概览
简要总结
Fiberoptic bronchoscopy plays a very important role in the diagnosis and treatment of respiratory diseases in children.In China,this procedure is mainly performed under two different anesthesia methods：sedation and general anesthesia(GA) . Which is better ? there are still a lot of controversies . Several early retrospective studies suggest that, in addition to the possible increase in costs, general anesthesia in intraoperative complications, postoperative recovery and other aspects did not bring significant improvement. But clinically we observed that children under sedation often can not cooperate, they often shows anxiety,restless,crying,and so on, under these situation, some restraint measures may be used, which may have an impact on the child's neuropsychological development. Therefore ,we design this study ,aiming to compare the influence between sedation and general anesthesia (GA) on children 's neuropsychological development.
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
- 4 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 4-10 years
- •American society of anesthesiologists(ASA) gradeⅠ～Ⅱ
- •Plan to accept fiberoptic bronchoscopy treatment
- •lives in the city where the research unit is located
- •signed informed consent
排除标准
- •preterm infants less than 28 weeks of gestational age or preoperative screening found that development, cognitive or behavioral abnormalities
- •known congenital malformations may have a potential impact on the development of children's neuropsychological function
- •known to have central nervous system disorders or meet the diagnostic criteria of Diagnostic and Statistical Manual(DSM) mental illness
- •children with contraindications to intravenous general anesthesia
结局指标
主要结局
The detection rate of abnormal behavior in both groups
时间窗: Three years after operation
Using the Achenbach Child Behavior Checklist(CBCL)for Parents.The CBCL is a widely used parent report questionnaire identifying behavioural and emotional problems in children. The CBCL is administered in interview format and respondents are asked to rate 112 problem items as 0 for "not true of the child," 1 for "somewhat or sometimes true of the child," and 2 for "very true or often true of the child", based on the past two months. The raw scores from the 112 items are then compared with age- and gender-matched controls from the standardization sample, and standard scores are then derived with a mean of 50 and a standard deviation of 10. Worst value is 80; best value is 30.
次要结局
- Full Scale Intelligence Quotient (FSIQ) Score of the Wechsler Intelligence Scale for Children (WISC)-IV(Three years after operation)