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NCT Number: NCT06367062

General Anesthesia/Surgical Exposure on White Matter Development in Children

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.

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Key information

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Currently between 12 and 15 years of age

Exclusion criteria

  • Surgical complications such as acute infectious diseases, systemic diseases
  • Abnormal findings on cerebral white matter and/or neurobehavioral assessment
  • History of neonatal ischemic-hypoxic encephalopathy, bilirubin encephalopathy
  • Genetic or chromosomal disorders, neurological disorders (including epilepsy, congenital disorders), or a history of craniocerebral trauma, infectious diseases of the central nervous system, febrile convulsions, congenital heart disease, oncological diseases, and blood disorders
  • Autism, attention deficit hyperactivity disorder, or those who have received behavioral therapy and intervention.
  • Children with organic damage to the nervous system
  • Cardiovascular surgery, neurosurgery or intraoperative hemodynamic instability.

Treatment and study plan

MRI

Other

MRI is used to assess of brain development.

Primary outcomes

  1. MRI-based assessment of brain development

    Time frame: one time, through study completion, an average of 3 month

    Magnetic resonance scanning of T1-weighted images, T2-weighted images, and diffusion tensor imaging (DTI) of both cerebral hemispheres, looking at whole-brain white matter volume as a percentage of total intracranial volume

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 16, 2024
Registry last updated
Apr 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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