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Clinical Trials/NCT06315933
NCT06315933
Recruiting
Not Applicable

Long-term Effect of General Anesthesia Before School Age on Neurodevelopment in Children With Congenital Scoliosis

Peking Union Medical College Hospital1 site in 1 country150 target enrollmentJuly 13, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
General Anesthetics Toxicity
Sponsor
Peking Union Medical College Hospital
Enrollment
150
Locations
1
Primary Endpoint
full-scale intelligence quotient, FSIQ
Status
Recruiting
Last Updated
5 months ago

Overview

Brief Summary

In the past, a large number of animal studies have suggested that anesthesia exposure has potential neurotoxic effects, resulting in persistent cognitive and behavioral deficits. At present, there is still a lack of sufficient clinical research evidence to prove whether anesthesia exposure has long-term effects on neurodevelopment. The existing clinical research data suggests that a single short-time anesthesia exposure in young children does not affect long-term neurodevelopmental outcomes. Early onset scoliosis, including congenital scoliosis, is a type of scoliosis deformity that occurs before the age of 10. Posterior scoliosis correction surgery is one of the common treatment. There is currently no research indicating the impact of early single or multiple long-duration anesthesia exposure on the neurological development of children with congenital scoliosis. The aim of this study is to determine the long-term effect of general anesthesia exposure on neurocognitive function and behavior in children with congenital scoliosis, in order to provide reference for related clinical work.

Registry
clinicaltrials.gov
Start Date
July 13, 2020
End Date
December 1, 2026
Last Updated
5 months ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lulu Ma

Chief physician, Professor

Peking Union Medical College Hospital

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with congenital scoliosis
  • 6-16 years old at the time of assessment

Exclusion Criteria

  • Cognitive impairment caused by congenital, traumatic or other reasons;
  • Existence of mental or psychological disorders;
  • There are factors that may affect neurological development, including any known central nervous system disease, neurological injury, or history of neonatal asphyxia;
  • Unable to cooperate with cognitive function tests;
  • The child is unable to communicate in Chinese.

Outcomes

Primary Outcomes

full-scale intelligence quotient, FSIQ

Time Frame: At the time of collecting baseline demographic data

Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)

Secondary Outcomes

  • Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI)(At the time of collecting baseline demographic data)
  • CBCL Total score, CBCL Internalizing score, CBCL Externalizing score(Within six months of WISC-IV assessment)
  • SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior score(Within six months of WISC-IV assessment)

Study Sites (1)

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