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Autism & Anesthetic Exposure Study

T

The Hospital for Sick Children

Status

Completed

Conditions

Autism Spectrum Disorder

Treatments

Procedure: Dental surgery

Study type

Observational

Funder types

Other

Identifiers

NCT03514498
1000057105

Details and patient eligibility

About

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.

Full 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.

Enrollment

51 patients

Sex

All

Ages

4 to 12 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

51 participants in 2 patient groups

Autism Spectrum Disorder
Description:
Children aged 4-12 years with a clinical diagnosis of mild-to-moderate Autism Spectrum Disorder undergoing dental surgery
Treatment:
Procedure: Dental surgery
Typically Developed Controls
Description:
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
Treatment:
Procedure: Dental surgery

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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