Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

Официальное название

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

Обзор

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.

Вмешательства

• Процедура General anesthesia
  General anesthesia including inhaled and intravenous

Первичные конечные точки

• full-scale intelligence quotient, FSIQ [Срок оценки: At the time of collecting baseline demographic data]

Вторичные конечные точки (3)

• Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI) [Срок оценки: At the time of collecting baseline demographic data]
• CBCL Total score, CBCL Internalizing score, CBCL Externalizing score [Срок оценки: Within six months of WISC-IV assessment]
• SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior score [Срок оценки: Within six months of WISC-IV assessment]

Критерии участия

Критерии включения

• Diagnosed with congenital scoliosis
• 6-16 years old at the time of assessment

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Публикации

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• Zaccariello MJ, Frank RD, Lee M, Kirsch AC, Schroeder DR, Hanson AC, Schulte PJ, Wilder RT, Sprung J, Katusic SK, Flick RP, Warner DO. Patterns of neuropsychological changes after general anaesthesia in young children: secondary analysis of the Mayo Anesthesia Safety in Kids study. Br J Anaesth. 2019 May;122(5):671-681. doi: 10.1016/j.bja.2019.01.022. PMID 30982593
• Baky FJ, Milbrandt TA, Flick R, Larson AN. Cumulative Anesthesia Exposure in Patients Treated for Early-Onset Scoliosis. Spine Deform. 2018 Nov-Dec;6(6):781-786. doi: 10.1016/j.jspd.2018.05.001. PMID 30348358
• Ruiz G, Torres-Lugo NJ, Marrero-Ortiz P, Guzman H, Olivella G, Ramirez N. Early-onset scoliosis: a narrative review. EFORT Open Rev. 2022 Aug 4;7(8):599-610. doi: 10.1530/EOR-22-0040. PMID 35924646

Идентификаторы

NCT: NCT06315933 · S-K1093

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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