Autism & Anesthetic Exposure Study

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

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.

Study Overview

• Status: Completed
• Conditions: Autism Spectrum Disorder
• Intervention / Treatment: Procedure: Dental surgery

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 Type: Observational
• Enrollment (Actual): 51

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 1X8
      • The Hospital for Sick Children

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 12 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children undergoing dental surgery at The Hospital for Sick Children

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Autism Spectrum Disorder; Children aged 4-12 years with a clinical diagnosis of mild-to-moderate Autism Spectrum Disorder undergoing dental surgery	Procedure: Dental surgery; 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	Procedure: Dental surgery; All types of dental surgery

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: The Hospital for Sick Children
• Investigators: Principal Investigator: Mark Crawford, The Hospital for Sick Children

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 28, 2018
• Primary Completion (ACTUAL): May 31, 2020
• Study Completion (ACTUAL): May 31, 2020

Study Registration Dates

• First Submitted: March 29, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (ACTUAL): May 2, 2018

Study Record Updates

• Last Update Posted (ACTUAL): December 17, 2021
• Last Update Submitted That Met QC Criteria: December 16, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Keywords: anesthesia
• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Child Development Disorders, Pervasive; Autistic Disorder; Autism Spectrum Disorder
• Other Study ID Numbers: 1000057105

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No