Autism & Anesthetic Exposure Study

Completed

• Conditions: Autism Spectrum Disorder
• Interventions: Procedure: Dental surgery

• 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.

Study Timeline

• Study Start: 2018-03-28
• Study First Submitted: 2018-03-29
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-05-02
• Primary Completion: 2020-05-31
• Study Completion: 2020-05-31
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-16
• Last Update Posted: 2021-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

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

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 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
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

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada