NCT06367062

General Anesthesia/Surgical Exposure on White Matter Development in Children

A Study of the Effects of General Anesthesia/Surgical Exposure on Distant Cerebral White Matter Development in Children

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 210 (estimated)
• Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University · Academic / Other
• Sex: All
• Age: 12 Years – 15 Years
• Healthy volunteers: —

Summary

International large-scale clinical studies have found that prolonged or repeated exposure to general anesthesia drugs in infancy and early childhood can lead to an increased risk of long-term neurodevelopmental abnormalities in children. The study of neurodevelopmental toxicity of general anesthesia drugs is of great social significance. We have established a rhesus monkey model to study the neurodevelopmental toxicity of general anesthetic drugs, the first time to make a preliminary exploration of the mechanism of myelin developmental toxicity of general anesthetic drugs. Several studies using magnetic resonance scanning found a positive correlation between the number of anesthesia exposures and the maturity of distant brain white matter development in juvenile non-human primates. Clinical evidence for myelin developmental toxicity induced by general anesthetic drugs needs to be collected by conducting multicenter and large-sample clinical studies. Earlier studies have either had low sample sizes, which do not allow for better control of confounding factors; or the study population has been limited to specific disease populations, and the results cannot be extrapolated to normal children. In view of this, based on the applicant's earlier study, this project proposes to recruit children who underwent general anesthesia surgery between 0-3 years of age and are now 12-15 years old; children who did not experience surgery between 0-3 years of age were matched by age-sex to serve as a control group. MRI will be used to assess their brain white matter development, to explore the correlation between anesthesia and anesthesia-related factors and brain white matter development and related neurobehavioral development, and to clarify the effects of anesthesia and surgery on children's brain white matter and related neuropsychological development.

Conditions

• Neurodevelopmental Delay

Interventions

Type	Name	Description
OTHER	MRI	MRI is used to assess of brain development.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-11-30
• Completion: 2026-12-31
• First posted: 2024-04-16
• Last updated: 2024-04-16