Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

Recruiting

• Conditions: General Anesthetics Toxicity
• Interventions: Procedure: General anesthesia

• Registration Number: NCT06315933
• Lead Sponsor: Peking Union Medical College Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-13
• Study First Submitted: 2024-03-12
• Study First Submitted QC: 2024-03-12
• Study First Posted: 2024-03-18
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-05-01
• Primary Completion: 2025-12
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Singly exposed	General anesthesia	Children singly exposed to general anesthesia before school age (\<=6y)
Multiply exposed	General anesthesia	Children multiply exposed to general anesthesia before school age (\<=6y)

Primary Outcome Measures

Name	Time	Method
full-scale intelligence quotient, FSIQ	At the time of collecting baseline demographic data	Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China