Clinical trial NCT06315933: Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children
Official title: Long-term Effect of General Anesthesia Before School Age on Neurodevelopment in Children With Congenital Scoliosis
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: General Anesthetics Toxicity
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-03-18
Enrollment: 100
Sex: ALL
Minimum age (years): 6
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children diagnosed with congenital scoliosis

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.


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.

Primary outcomes:
measure: full-scale intelligence quotient, FSIQ
timeFrame: At the time of collecting baseline demographic data
Secondary outcomes:
measure: Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI)
timeFrame: At the time of collecting baseline demographic data
measure: CBCL Total score, CBCL Internalizing score, CBCL Externalizing score
timeFrame: Within six months of WISC-IV assessment
measure: SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior score
timeFrame: Within six months of WISC-IV assessment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Lulu Ma, Dr.
role: PRINCIPAL_INVESTIGATOR
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