Autism & Anesthetic Exposure Study
- Conditions
- Autism Spectrum Disorder
- Registration Number
- NCT03514498
- Lead Sponsor
- The Hospital for Sick Children
- Brief Summary
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.
- Detailed Description
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:
1. to determine in a clinical study if anesthesia induces post-operative persistent adverse changes children with ASD as compared with typically developing controls;
2. 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Regression in language and behaviour skills up to 12 weeks following anesthetic exposure measured using the Autism Diagnostic Interview - Revised
Current language and behaviour skills up to 3 months before surgery measured using the Autism Diagnostic Interview - Revised
- Secondary Outcome Measures
Name Time Method Metabolic changes within 1-2 hours following anesthetic exposure measured using quantitative polymerase chain reactions
Regression in sleep habits up to 12 weeks following anesthetic exposure measured using the Children's Sleep Habits Questionnaire
Current social responsiveness skills up to 3 months before surgery measured using the Social Responsiveness Scale
Metabolic make-up immediately prior to anesthetic exposure measured using quantitative polymerase chain reactions
Current sleep habits up to 3 months before surgery measured using the Children's Sleep Habits Questionnaire
Posthospitalization Behaviours 3 days following anesthetic exposure measured using the Posthospitalization Behaviour Questionnaire
Current social communication skills up to 3 months before surgery measured using the Social Communication Questionnaire
Regression in social communication skills up to 12 weeks following anesthetic exposure measured using the Social Communication Questionnaire
Regression in social responsiveness skills up to 12 weeks following anesthetic exposure measured using the Social Responsiveness Scale
Current non-specific behaviour skills up to 3 months before surgery measured using the Abberant Behaviour Checklist
Regression in non-specific behaviour skills up to 12 weeks following anesthetic exposure measured using the Abberant Behaviour Checklist
Changes in posthospitalization behaviours up to 12 weeks following anesthetic exposure measured using semi-structured interview
Trial Locations
- Locations (1)
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
The Hospital for Sick Children🇨🇦Toronto, Ontario, Canada