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RecruitingNCT06315933Updated Nov 18, 2025

Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

An observational study in General Anesthetics Toxicity, sponsored by Peking Union Medical College Hospital. Recruiting at 1 site in China. Open to participants aged 6 Years to 16 Years. Per ClinicalTrials.gov, last updated 2025-11-18.

Sponsored by Peking Union Medical College Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 10 months ago, but the record still lists the study as recruiting.
  • Started Jul 2020; still recruiting 6 years 2 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
150
Ages
6 Years to 16 Years
Sex
All
01

Study 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.

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Conditions studied

  • General Anesthetics Toxicity
03

In context

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 16 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Children diagnosed with congenital scoliosis

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
150 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • ProcedureGeneral anesthesia

    General anesthesia including inhaled and intravenous

06

What researchers measure

Primary outcomes

  1. full-scale intelligence quotient, FSIQ

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

    Time frame: At the time of collecting baseline demographic data

Secondary outcomes

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

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

    Time frame: At the time of collecting baseline demographic data

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

    Measured by Child Behavior Checklist (CBCL)

    Time frame: Within six months of WISC-IV assessment

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

    Measured by Strengths and Difficulties Questionnaire (SDQ)

    Time frame: Within six months of WISC-IV assessment

07

Study locations

1 of 1 sites recruiting
  • Peking Union Medical College Hospital
    Beijing, Beijing Municipality 100730, China
    Recruiting
08

References and documents

Publications

  • 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. PubMed 23460572 ↗
  • 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. PubMed 23109147 ↗
  • 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. PubMed 20124985 ↗
  • 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. PubMed 26002228 ↗
  • 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. PubMed 30782342 ↗
  • 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. PubMed 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. PubMed 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. PubMed 35924646 ↗
  • 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. PubMed 29258430 ↗
  • 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. PubMed 30703588 ↗
  • 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. PubMed 41338617 ↗

Individual participant data

Plan to share: Yes — IPD that underlie results in a publication

Supporting information: Study protocol, Sap, Icf, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 18, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06315933
Lead sponsor
Peking Union Medical College Hospital
Responsible party
Lulu Ma (Chief physician, Professor, Peking Union Medical College Hospital) — Principal investigator
First posted
Mar 18, 2024
Start date
Jul 13, 2020
Primary completion
Dec 2025 (estimated)
Completion
Dec 2026 (estimated)
Last update
Nov 18, 2025

Study contacts

Lulu Ma, Dr.
Contact
malulu@pumch.cn
0086-10-13811049619
Ziyi Dai, Dr.
Contact
daiziyi@pumch.cn
0086-10-18611703606
Lulu Ma, Dr.
principal investigator · Peking Union Medical College Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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