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Completed

NCT Number: NCT03514498

Autism & Anesthetic Exposure 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.

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Key information

Conditions

Autism Spectrum Disorder Child Development Disorders, Pervasive Mental Disorders Neurodevelopmental Disorders

Age range

4 year–12 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dental surgery

Procedure

All types of dental surgery

Primary outcomes

  1. Current language and behaviour skills

    Time frame: up to 3 months before surgery

    measured using the Autism Diagnostic Interview - Revised

  2. Regression in language and behaviour skills

    Time frame: up to 12 weeks following anesthetic exposure

    measured using the Autism Diagnostic Interview - Revised

Secondary outcomes

  1. Metabolic make-up

    Time frame: immediately prior to anesthetic exposure

    measured using quantitative polymerase chain reactions

  2. Metabolic changes

    Time frame: within 1-2 hours following anesthetic exposure

    measured using quantitative polymerase chain reactions

  3. Current non-specific behaviour skills

    Time frame: up to 3 months before surgery

    measured using the Abberant Behaviour Checklist

  4. Regression in non-specific behaviour skills

    Time frame: up to 12 weeks following anesthetic exposure

    measured using the Abberant Behaviour Checklist

  5. Current sleep habits

    Time frame: up to 3 months before surgery

    measured using the Children's Sleep Habits Questionnaire

  6. Regression in sleep habits

    Time frame: up to 12 weeks following anesthetic exposure

    measured using the Children's Sleep Habits Questionnaire

  7. Current social communication skills

    Time frame: up to 3 months before surgery

    measured using the Social Communication Questionnaire

  8. Regression in social communication skills

    Time frame: up to 12 weeks following anesthetic exposure

    measured using the Social Communication Questionnaire

  9. Current social responsiveness skills

    Time frame: up to 3 months before surgery

    measured using the Social Responsiveness Scale

  10. Regression in social responsiveness skills

    Time frame: up to 12 weeks following anesthetic exposure

    measured using the Social Responsiveness Scale

  11. Posthospitalization Behaviours

    Time frame: 3 days following anesthetic exposure

    measured using the Posthospitalization Behaviour Questionnaire

  12. Changes in posthospitalization behaviours

    Time frame: up to 12 weeks following anesthetic exposure

    measured using semi-structured interview

Sponsors and collaborators

Lead sponsor

The Hospital for Sick Children

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 2, 2018
Registry last updated
Dec 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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