Autism & Anesthetic Exposure Study

Autism Spectrum Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03514498
• Other study ID #: 1000057105
• Status: Completed
• Start date: March 28, 2018
• Est. completion date: May 31, 2020

Study information

• Verified date: December 2021
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: May 31, 2020
• Est. primary completion date: May 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 4 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Autism Spectrum Disorder
• Autistic Disorder

Intervention

Procedure:
• Dental surgery
All types of dental surgery

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Current language and behaviour skills	measured using the Autism Diagnostic Interview - Revised	up to 3 months before surgery
Primary	Regression in language and behaviour skills	measured using the Autism Diagnostic Interview - Revised	up to 12 weeks following anesthetic exposure
Secondary	Metabolic make-up	measured using quantitative polymerase chain reactions	immediately prior to anesthetic exposure
Secondary	Metabolic changes	measured using quantitative polymerase chain reactions	within 1-2 hours following anesthetic exposure
Secondary	Current non-specific behaviour skills	measured using the Abberant Behaviour Checklist	up to 3 months before surgery
Secondary	Regression in non-specific behaviour skills	measured using the Abberant Behaviour Checklist	up to 12 weeks following anesthetic exposure
Secondary	Current sleep habits	measured using the Children's Sleep Habits Questionnaire	up to 3 months before surgery
Secondary	Regression in sleep habits	measured using the Children's Sleep Habits Questionnaire	up to 12 weeks following anesthetic exposure
Secondary	Current social communication skills	measured using the Social Communication Questionnaire	up to 3 months before surgery
Secondary	Regression in social communication skills	measured using the Social Communication Questionnaire	up to 12 weeks following anesthetic exposure
Secondary	Current social responsiveness skills	measured using the Social Responsiveness Scale	up to 3 months before surgery
Secondary	Regression in social responsiveness skills	measured using the Social Responsiveness Scale	up to 12 weeks following anesthetic exposure
Secondary	Posthospitalization Behaviours	measured using the Posthospitalization Behaviour Questionnaire	3 days following anesthetic exposure
Secondary	Changes in posthospitalization behaviours	measured using semi-structured interview	up to 12 weeks following anesthetic exposure