General Anesthetics ToxicityNCT06315933

Anesthesia Neurodevelopmental Impact in Congenital Scoliosis Children

An observational study of General Anesthetics Toxicity, run by Peking Union Medical College Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 6 to 16 years
Conditions the study is for: General Anesthetics Toxicity
What is being tested?: General anesthesia
Type of treatment: Injection or infusion, Surgery or procedure
How many people: 150 participants
Where: 1 siteChina
Study dates: 13 Jul 2020to Dec 2026
Phase: Observational
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 16 years
All sexes
No healthy volunteers
Child

Study population: Children diagnosed with congenital scoliosis

Who may be able to join

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

Who cannot join

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 locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Lulu Ma, Dr. contact

0086-10-13811049619

malulu@pumch.cn

Ziyi Dai, Dr. contact

0086-10-18611703606

daiziyi@pumch.cn

China1 site, 1 recruiting

Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100730
Lulu Ma, Dr., 0086-010-13811049619, malulu@pumch.cn
Recruiting

Other trials in China

About this study

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

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
Being tested: General anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

General anesthesiaProcedure or surgery
General anesthesia including inhaled and intravenous

Study groups in NCT06315933
Study group	Role	What they receive
Unexposed		Children unexposed to general anesthesia before school age (<=6y)
Singly exposed		Children singly exposed to general anesthesia before school age (<=6y) Receives: Procedure: General anesthesia
Multiply exposed		Children multiply exposed to general anesthesia before school age (<=6y) Receives: Procedure: General anesthesia

What is being measured

The primary outcome is the main question the study is designed to answer.

full-scale intelligence quotient, FSIQ
Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)
Measured: At the time of collecting baseline demographic data

Secondary outcomes (3)

Verbal Comprehension Index (VCI), Perceptual Reasoning/Organization Index (PRI/POI)
Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)
Measured: At the time of collecting baseline demographic data
CBCL Total score, CBCL Internalizing score, CBCL Externalizing score
Measured by Child Behavior Checklist (CBCL)
Measured: Within six months of WISC-IV assessment
SDQ total difficulties score, SDQ internalizing problems score, SDQ externalizing problems score, SDQ prosocial behavior score
Measured by Strengths and Difficulties Questionnaire (SDQ)
Measured: Within six months of WISC-IV assessment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

13 Jul 2020Dec 2026

First posted18 Mar 2024
Study start13 Jul 2020
Primary completionDec 2025 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (11)Papers the sponsor has linked to this study.
Other trials for General Anesthetics ToxicityStudies of the same condition, open and under way.
More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 150 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06315933
Sponsor's protocol ID: S-K1093
Status last verified: Nov 2025
First submitted: 12 Mar 2024
Last updated: 18 Nov 2025
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: IPD that underlie results in a publication

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

Study at a glance

From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Long-term Effect of General Anesthesia Before School Age on Neurodevelopment in Children With Congenital Scoliosis
ClinicalTrials.gov ID: NCT06315933
Acronym / sponsor ID: S-K1093
Conditions: General Anesthetics Toxicity
Study type: Observational
Recruitment status: Recruiting
Enrolment: 150 participants (estimated)
Lead sponsor: Peking Union Medical College HospitalUniversity, hospital or other
Study start: 13 Jul 2020 (actual)
Primary completion: Dec 2025 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 18 Mar 2024 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Unexposed	–	–Children unexposed to general anesthesia before school age (<=6y)
Singly exposed	–	Procedure: General anesthesiaChildren singly exposed to general anesthesia before school age (<=6y)
Multiply exposed	–	Procedure: General anesthesiaChildren multiply exposed to general anesthesia before school age (<=6y)

Who may qualify

Ages: 6 to 16 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child
Study population: Children diagnosed with congenital scoliosis

Key inclusion criteria (2 listed)

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

Key exclusion criteria (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
General anesthesiaGeneral anesthesia including inhaled and intravenous	Procedure or surgery	Multiply exposed, Singly exposed

Primary outcome

full-scale intelligence quotient, FSIQ
Time frame: At the time of collecting baseline demographic data
Measured by Wechsler Intelligence Scale for Children-Fourth Edition (WISC-IV)

3 secondary outcomes

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

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
Background: PubMed 23460572Istaphanous 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.
Background: PubMed 23109147Brambrink 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.
Background: PubMed 20124985Briner 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.
Background: PubMed 26002228Zhang 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.
Background: PubMed 30782342McCann 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.
Background: PubMed 30982593Zaccariello 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.
Background: PubMed 30348358Baky 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.
Background: PubMed 35924646Ruiz 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.
Background: PubMed 29258430Zhang 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.
Background: PubMed 30703588Lin 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.
Derived from this study: PubMed 41338617Dai 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.
Individual participant dataSharing planned: Yes. IPD that underlie results in a publication

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Lulu Ma, Dr. contact

0086-10-13811049619

malulu@pumch.cn

Ziyi Dai, Dr. contact

0086-10-18611703606

daiziyi@pumch.cn

Lulu Ma, Dr. principal investigator

Peking Union Medical College Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of General Anesthetics Toxicity, run by Peking Union Medical College Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Lulu Ma, Dr. (0086-10-13811049619, malulu@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

full-scale intelligence quotient, FSIQ (time frame: At the time of collecting baseline demographic data). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06315933, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.