Autism & Anesthetic Exposure Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Cognitive, Behavioural and Metabolic Effects of Anesthesia in Patients With Autism Spectrum Disorder: a Pilot Study

Conditions
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Autism Spectrum Disorder

Intervention / Treatment
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* Procedure: Dental surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria For Autism Spectrum Disorder Group: child is undergoing dental surgery child is aged 4 to 12 years child has mild-to-moderate diagnosis of autism spectrum disorder child has an American Society of Anesthesiologists (ASA) Physical Status level I or II Exclusion Criteria for Autism Spectrum Disorder Group: - child does not use words or phrases to communicate Inclusion Criteria for Typically Developed Controls Group: child is undergoing dental surgery child is matched to an autism spectrum disorder participant according to age, gender, and ASA level

Ages Eligible for Study
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Minimum Age: 4 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Autism Spectrum Disorder<br>Children aged 4-12 years with a clinical diagnosis of mild-to-moderate Autism Spectrum Disorder undergoing dental surgery | Procedure: Dental surgery<br>* All types of dental surgery<br>|
| Typically Developed Controls<br>Children with no neurodevelopmental delays matched to Autism Spectrum Disorder participants according to age (within 6 months), gender, and ASA physical status level, scheduled to undergo dental surgery | Procedure: Dental surgery<br>* All types of dental surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Current language and behaviour skills | measured using the Autism Diagnostic Interview - Revised | up to 3 months before surgery | 
| Regression in language and behaviour skills | measured using the Autism Diagnostic Interview - Revised | up to 12 weeks following anesthetic exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic make-up | measured using quantitative polymerase chain reactions | immediately prior to anesthetic exposure | 
| Metabolic changes | measured using quantitative polymerase chain reactions | within 1-2 hours following anesthetic exposure | 
| Current non-specific behaviour skills | measured using the Abberant Behaviour Checklist | up to 3 months before surgery | 
| Regression in non-specific behaviour skills | measured using the Abberant Behaviour Checklist | up to 12 weeks following anesthetic exposure | 
| Current sleep habits | measured using the Children's Sleep Habits Questionnaire | up to 3 months before surgery | 
| Regression in sleep habits | measured using the Children's Sleep Habits Questionnaire | up to 12 weeks following anesthetic exposure | 
| Current social communication skills | measured using the Social Communication Questionnaire | up to 3 months before surgery | 
| Regression in social communication skills | measured using the Social Communication Questionnaire | up to 12 weeks following anesthetic exposure | 
| Current social responsiveness skills | measured using the Social Responsiveness Scale | up to 3 months before surgery | 
| Regression in social responsiveness skills | measured using the Social Responsiveness Scale | up to 12 weeks following anesthetic exposure | 
| Posthospitalization Behaviours | measured using the Posthospitalization Behaviour Questionnaire | 3 days following anesthetic exposure | 
| Changes in posthospitalization behaviours | measured using semi-structured interview | up to 12 weeks following anesthetic exposure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anesthesia