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Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

Chinese Academy of Medical Sciences & Peking Union Medical College logo

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Enrolling

Conditions

General Anesthetics Toxicity

Treatments

Procedure: General anesthesia

Study type

Observational

Funder types

Other

Identifiers

NCT06315933
S-K1093

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

6 to 16 years old

Volunteers

No Healthy Volunteers

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.

Trial design

150 participants in 3 patient groups

Unexposed
Description:
Children unexposed to general anesthesia before school age (\<=6y)
Singly exposed
Description:
Children singly exposed to general anesthesia before school age (\<=6y)
Treatment:
Procedure: General anesthesia
Multiply exposed
Description:
Children multiply exposed to general anesthesia before school age (\<=6y)
Treatment:
Procedure: General anesthesia

Trial contacts and locations

1

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Central trial contact

Ziyi Dai, Dr.; Lulu Ma, Dr.

Data sourced from clinicaltrials.gov

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