Clinical trial NCT03514498: Autism & Anesthetic Exposure Study
Official title: Cognitive, Behavioural and Metabolic Effects of Anesthesia in Patients With Autism Spectrum Disorder: a Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Keywords: anesthesia
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2018-05-02
Enrollment: 51
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children undergoing dental surgery at 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.

Eligibility 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

Primary outcomes:
measure: Current language and behaviour skills
timeFrame: up to 3 months before surgery
measure: Regression in language and behaviour skills
timeFrame: up to 12 weeks following anesthetic exposure
Secondary outcomes:
measure: Metabolic make-up
timeFrame: immediately prior to anesthetic exposure
measure: Metabolic changes
timeFrame: within 1-2 hours following anesthetic exposure
measure: Current non-specific behaviour skills
timeFrame: up to 3 months before surgery
measure: Regression in non-specific behaviour skills
timeFrame: up to 12 weeks following anesthetic exposure
measure: Current sleep habits
timeFrame: up to 3 months before surgery
measure: Regression in sleep habits
timeFrame: up to 12 weeks following anesthetic exposure
measure: Current social communication skills
timeFrame: up to 3 months before surgery
measure: Regression in social communication skills
timeFrame: up to 12 weeks following anesthetic exposure
measure: Current social responsiveness skills
timeFrame: up to 3 months before surgery
measure: Regression in social responsiveness skills
timeFrame: up to 12 weeks following anesthetic exposure
measure: Posthospitalization Behaviours
timeFrame: 3 days following anesthetic exposure
measure: Changes in posthospitalization behaviours
timeFrame: up to 12 weeks following anesthetic exposure
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Mark Crawford
role: PRINCIPAL_INVESTIGATOR
References: