Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Autism & Anesthetic Exposure Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03514498
Recruitment Status : Enrolling by invitation
First Posted : May 2, 2018
Last Update Posted : April 16, 2019
Sponsor:
Information provided by (Responsible Party):
Mark Crawford, 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.

Condition or disease Intervention/treatment
Autism Spectrum Disorder 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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Cognitive, Behavioural and Metabolic Effects of Anesthesia in Patients With Autism Spectrum Disorder: a Pilot Study
Actual Study Start Date : March 28, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  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 Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
Cell lines will be established from blood samples.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   4 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Children undergoing dental surgery at The Hospital for Sick Children
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03514498


Locations
Layout table for location information
Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
Investigators
Layout table for investigator information
Principal Investigator: Mark Crawford The Hospital for Sick Children

Layout table for additonal information
Responsible Party: Mark Crawford, Anesthesiologist-in-Chief, The Hospital for Sick Children
ClinicalTrials.gov Identifier: NCT03514498     History of Changes
Other Study ID Numbers: 1000057105
First Posted: May 2, 2018    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark Crawford, The Hospital for Sick Children:
anesthesia

Additional relevant MeSH terms:
Layout table for MeSH terms
Autistic Disorder
Autism Spectrum Disorder
Child Development Disorders, Pervasive
Neurodevelopmental Disorders
Mental Disorders