Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

NCT06315933 | Recruiting

• 1 other identifier: S-K1093
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

General Anesthetics Toxicity

Outcome Measures

Primary Outcomes (1)

• full-scale intelligence quotient, FSIQ

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

  At the time of collecting baseline demographic data

Secondary Outcomes (3)

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

  At the time of collecting baseline demographic data

• CBCL Total score, CBCL Internalizing score, CBCL Externalizing score

  Within six months of WISC-IV assessment

• SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior score

  Within six months of WISC-IV assessment

Study Arms (3)

Unexposed

Children unexposed to general anesthesia before school age (\<=6y)

Singly exposed

Children singly exposed to general anesthesia before school age (\<=6y)

Procedure: General anesthesia

Multiply exposed

Children multiply exposed to general anesthesia before school age (\<=6y)

Procedure: General anesthesia

Interventions

General anesthesia PROCEDURE

General anesthesia including inhaled and intravenous

Multiply exposed; Singly exposed

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

Children diagnosed with congenital scoliosis

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

RECRUITING

Related Publications (11)

• Istaphanous GK, Ward CG, Nan X, Hughes EA, McCann JC, McAuliffe JJ, Danzer SC, Loepke AW. Characterization and quantification of isoflurane-induced developmental apoptotic cell death in mouse cerebral cortex. Anesth Analg. 2013 Apr;116(4):845-54. doi: 10.1213/ANE.0b013e318281e988. Epub 2013 Mar 4.

  PMID: 23460572 BACKGROUND

• Brambrink AM, Back SA, Riddle A, Gong X, Moravec MD, Dissen GA, Creeley CE, Dikranian KT, Olney JW. Isoflurane-induced apoptosis of oligodendrocytes in the neonatal primate brain. Ann Neurol. 2012 Oct;72(4):525-35. doi: 10.1002/ana.23652.

  PMID: 23109147 BACKGROUND

• Briner A, De Roo M, Dayer A, Muller D, Habre W, Vutskits L. Volatile anesthetics rapidly increase dendritic spine density in the rat medial prefrontal cortex during synaptogenesis. Anesthesiology. 2010 Mar;112(3):546-56. doi: 10.1097/ALN.0b013e3181cd7942.

  PMID: 20124985 BACKGROUND

• Zhang H, Du L, Du Z, Jiang H, Han D, Li Q. Association between childhood exposure to single general anesthesia and neurodevelopment: a systematic review and meta-analysis of cohort study. J Anesth. 2015 Oct;29(5):749-57. doi: 10.1007/s00540-015-2030-z. Epub 2015 May 23.

  PMID: 26002228 BACKGROUND

• McCann ME, de Graaff JC, Dorris L, Disma N, Withington D, Bell G, Grobler A, Stargatt R, Hunt RW, Sheppard SJ, Marmor J, Giribaldi G, Bellinger DC, Hartmann PL, Hardy P, Frawley G, Izzo F, von Ungern Sternberg BS, Lynn A, Wilton N, Mueller M, Polaner DM, Absalom AR, Szmuk P, Morton N, Berde C, Soriano S, Davidson AJ; GAS Consortium. Neurodevelopmental outcome at 5 years of age after general anaesthesia or awake-regional anaesthesia in infancy (GAS): an international, multicentre, randomised, controlled equivalence trial. Lancet. 2019 Feb 16;393(10172):664-677. doi: 10.1016/S0140-6736(18)32485-1. Epub 2019 Feb 14.

  PMID: 30782342 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Zhang Q, Peng Y, Wang Y. Long-duration general anesthesia influences the intelligence of school age children. BMC Anesthesiol. 2017 Dec 19;17(1):170. doi: 10.1186/s12871-017-0462-8.

  PMID: 29258430 BACKGROUND

• Lin T, Meng Y, Ji Z, Jiang H, Shao W, Gao R, Zhou X. Extent of Depression in Juvenile and Adolescent Patients with Idiopathic Scoliosis During Treatment with Braces. World Neurosurg. 2019 Jun;126:e27-e32. doi: 10.1016/j.wneu.2019.01.095. Epub 2019 Jan 29.

  PMID: 30703588 BACKGROUND

• Dai Z, Zhang Y, Ma L, Zhang J, Huang Y. Association between general anaesthesia exposure and neurodevelopment in children with congenital scoliosis at a Chinese tertiary hospital: study protocol for a prospective longitudinal observational cohort study. BMJ Open. 2025 Dec 2;15(12):e108845. doi: 10.1136/bmjopen-2025-108845.

  PMID: 41338617 DERIVED

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Study Officials

• Lulu Ma, Dr.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lulu Ma, Dr.

CONTACT

0086-10-13811049619; malulu@pumch.cn

Ziyi Dai, Dr.

CONTACT

0086-10-18611703606; daiziyi@pumch.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician, Professor

Study Record Dates

• First Submitted: March 12, 2024
• First Posted: March 18, 2024
• Study Start: July 13, 2020
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: starting 1 year after the results are published
• Access Criteria: IPD is available on appropriate request from the Principle Investigator by email

Locations

CN (1)