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Autism & Anesthetic Exposure Study

NCT ID: NCT03514498

Last Updated: 2021-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-03-28

Study Completion Date

2020-05-31

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:

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.

Conditions

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Autism Spectrum Disorder

Keywords

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anesthesia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Autism Spectrum Disorder

Children aged 4-12 years with a clinical diagnosis of mild-to-moderate Autism Spectrum Disorder undergoing dental surgery

Dental surgery

Intervention Type PROCEDURE

All types of dental surgery

Typically Developed Controls

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

Dental surgery

Intervention Type PROCEDURE

All types of dental surgery

Interventions

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Dental surgery

All types of dental surgery

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* 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


* child is undergoing dental surgery
* child is matched to an autism spectrum disorder participant according to age, gender, and ASA level

Exclusion Criteria

\- child does not use words or phrases to communicate
Minimum Eligible Age

4 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Hospital for Sick Children

OTHER

Sponsor Role lead

Responsible Party

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Mark Crawford

Anesthesiologist-in-Chief

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mark Crawford

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

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The Hospital for Sick Children

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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1000057105

Identifier Type: -

Identifier Source: org_study_id