Cognitive, Behavioural and Metabolic Effects of Anesthesia in Patients With Autism Spectrum Disorder: a Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 1
- 主要终点
- Regression in language and behaviour skills
研究概览
简要总结
As anesthesia is often needed for childhood surgery and procedures, researchers have examined the potential effects of anesthesia on neurodevelopment. There are few studies that have examined the effect of anesthesia on neurodevelopment in children with confirmed diagnoses of ASD, and the results of these studies are mixed. Children with neurodevelopmental disorders can have age-dependent variations in brain anatomy, function, and connectivity, which may alter their sensitivity to the potential neurotoxic effects of anesthetic and sedative drugs. Given the potential adverse neurodevelopmental effects of anesthesia on typically developing children, it is important to examine if anesthesia exposure can worsen the clinical course of ASD.
详细描述
We hypothesize that children with a confirmed diagnosis of ASD will regress developmentally following general anesthesia for dental surgery in comparison to children without ASD (controls) undergoing dental surgery. In this pilot study, we will investigate this hypothesis through the following objectives:
- to determine in a clinical study if anesthesia induces post-operative persistent adverse changes children with ASD as compared with typically developing controls;
- to determine the potential mechanism for the adverse effects of anesthetics on patients with ASD compared to healthy controls, peripheral blood mononuclear cells will be isolated from blood samples (PBMCs), before genomic DNA isolation for mitochondrial content analysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Regression in language and behaviour skills
时间窗: up to 12 weeks following anesthetic exposure
measured using the Autism Diagnostic Interview - Revised
Current language and behaviour skills
时间窗: up to 3 months before surgery
measured using the Autism Diagnostic Interview - Revised
次要结局
- Regression in sleep habits(up to 12 weeks following anesthetic exposure)
- Current social responsiveness skills(up to 3 months before surgery)
- Metabolic make-up(immediately prior to anesthetic exposure)
- Current sleep habits(up to 3 months before surgery)
- Posthospitalization Behaviours(3 days following anesthetic exposure)
- Current social communication skills(up to 3 months before surgery)
- Regression in social communication skills(up to 12 weeks following anesthetic exposure)
- Regression in social responsiveness skills(up to 12 weeks following anesthetic exposure)
- Current non-specific behaviour skills(up to 3 months before surgery)
- Metabolic changes(within 1-2 hours following anesthetic exposure)
- Regression in non-specific behaviour skills(up to 12 weeks following anesthetic exposure)
- Changes in posthospitalization behaviours(up to 12 weeks following anesthetic exposure)
研究者
Mark Crawford
Anesthesiologist-in-Chief
The Hospital for Sick Children