Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

General Anesthetics Toxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06315933
• Other study ID #: S-K1093
• Status: Recruiting
• Start date: January 13, 2020
• Est. completion date: December 2026

Study information

• Verified date: March 2024
• Source: Peking Union Medical College Hospital
• Contact: Lulu Ma, Dr.
• Phone: 0086-010-13811049619
• Email: malulu[@]pumch.cn
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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 risk factors that may affect neurological development, such as central nervous system diseases and history of neonatal asphyxia;
• Unable to cooperate with cognitive function tests;
• Refuse to cooperate;
• The child is unable to communicate in Chinese;
• There may be difficulties in follow-up.

Related Conditions & MeSH terms

• General Anesthetics Toxicity
• Scoliosis

Intervention

Procedure:
• General anesthesia
General anesthesia inluding inhaled and intravenous

Locations

Country	Name	City	State
China	Peking Union Medical College Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

References & Publications (10)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Lancet. 2019 Aug 24;394(10199):638. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	full-scale intelligence quotient, FSIQ	Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)	At the time of collecting baseline demographic data (at least six months after the last surgery)
Secondary	Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI), Working Memory Index (WMI), Processing Speed Index (PSI)	Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)	At the time of collecting baseline demographic data (at least six months after the last surgery)
Secondary	CBCL Total score, CBCL Internalizing score, CBCL Externalizing score	Measured by Child Behavior Checklist (CBCL)	Within six months of WISC-IV assessment
Secondary	SDQ Emotional symptoms, SDQ conduct problems, SDQ hyperactivity, SDQ peer problems, SDQ total difficulties, SDQ prosocial behaviors, SDQ impact factor	Measured by Strengths and Difficulties Questionnaire (SDQ)	Within six months of WISC-IV assessment