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Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06315933
Enrollment
150
Registered
2024-03-18
Start date
2020-07-13
Completion date
2026-12-31
Last updated
2025-11-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General Anesthetics Toxicity

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.

Interventions

PROCEDUREGeneral anesthesia

General anesthesia including inhaled and intravenous

Sponsors

Peking Union Medical College Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
full-scale intelligence quotient, FSIQAt the time of collecting baseline demographic dataMeasured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)

Secondary

MeasureTime frameDescription
Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI)At the time of collecting baseline demographic dataMeasured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)
CBCL Total score, CBCL Internalizing score, CBCL Externalizing scoreWithin six months of WISC-IV assessmentMeasured by Child Behavior Checklist (CBCL)
SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior scoreWithin six months of WISC-IV assessmentMeasured by Strengths and Difficulties Questionnaire (SDQ)

Countries

China

Contacts

Primary ContactLulu Ma, Dr.
malulu@pumch.cn0086-10-13811049619
Backup ContactZiyi Dai, Dr.
daiziyi@pumch.cn0086-10-18611703606

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026