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NCT Number: NCT06315933

Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

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.

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Key information

Age range

6 year–16 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location status: Recruiting

Location contact

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General Anesthesia

Procedure

General anesthesia including inhaled and intravenous

Primary outcomes

  1. 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

  1. Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI)

    Time frame: At the time of collecting baseline demographic data

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

  2. CBCL Total score, CBCL Internalizing score, CBCL Externalizing score

    Time frame: Within six months of WISC-IV assessment

    Measured by Child Behavior Checklist (CBCL)

  3. SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior score

    Time frame: Within six months of WISC-IV assessment

    Measured by Strengths and Difficulties Questionnaire (SDQ)

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2025
Study completion
2026
First posted
Mar 18, 2024
Registry last updated
Nov 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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