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Clinical Trials/NCT03514498
NCT03514498
Completed
Not Applicable

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

The Hospital for Sick Children1 site in 1 country51 target enrollmentMarch 28, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Autism Spectrum Disorder
Sponsor
The Hospital for Sick Children
Enrollment
51
Locations
1
Primary Endpoint
Regression in language and behaviour skills
Status
Completed
Last Updated
4 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 28, 2018
End Date
May 31, 2020
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mark Crawford

Anesthesiologist-in-Chief

The Hospital for Sick Children

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Regression in language and behaviour skills

Time Frame: up to 12 weeks following anesthetic exposure

measured using the Autism Diagnostic Interview - Revised

Current language and behaviour skills

Time Frame: up to 3 months before surgery

measured using the Autism Diagnostic Interview - Revised

Secondary Outcomes

  • Regression in sleep habits(up to 12 weeks following anesthetic exposure)
  • Current social responsiveness skills(up to 3 months before surgery)
  • Metabolic make-up(immediately prior to anesthetic exposure)
  • Current sleep habits(up to 3 months before surgery)
  • Posthospitalization Behaviours(3 days following anesthetic exposure)
  • Current social communication skills(up to 3 months before surgery)
  • Regression in social communication skills(up to 12 weeks following anesthetic exposure)
  • Regression in social responsiveness skills(up to 12 weeks following anesthetic exposure)
  • Current non-specific behaviour skills(up to 3 months before surgery)
  • Metabolic changes(within 1-2 hours following anesthetic exposure)
  • Regression in non-specific behaviour skills(up to 12 weeks following anesthetic exposure)
  • Changes in posthospitalization behaviours(up to 12 weeks following anesthetic exposure)

Study Sites (1)

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