跳至主要内容
临床试验/NCT01229514
NCT01229514已完成不适用

A Comparison of Functional Magnetic Resonance Imaging (fMRI) Findings in Children With and Without a History of Early Exposure to General Anesthetics

Nationwide Children's Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2008年10月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Use of fMRI as a tool

研究概览

简要总结

General anesthetic medications have been shown to cause neuronal cell death in the brains of infant rodents. Ethanol and general anesthetics both act on NMDA and GABA receptors,and appear to have similar mechanisms of toxicity in the immature rodent brain. Functional MRI (fMRI) is a technique developed for mapping brain activation and has been utilized to examine how the brains of children with a history of early exposure to ethanol function differently from children without such a history. This study will utilize fMRI to look for specific changes in brain activation patterns in children with a history of early exposure to general anesthesia, as compared to children without such exposure.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
10 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children ages 10-17 years with an history of exposure to general anesthesia for at least one hour in duration during the ages of 0-24 months of age.
  • The cognitive ability to complete fMRI imaging.
  • Consent of the subject's guardians and assent of the subject.
  • Right hand dominance.
  • English language speaker.

排除标准

  • Subjects with known possibility or knowledge of pregnancy.
  • Documentation of hemodynamic or respiratory instability documented on the anesthetic record
  • Subjects with the inability to complete MRI imaging without sedation.
  • History of prenatal ethanol exposure.
  • History of exposure to antiepileptic medication.
  • History of Attention Deficit Disorder (ADD), or Attention Deficit Hyperactivity Disorder (ADHD)
  • History of traumatic brain injury
  • History of psychiatric disease or exposure to psychoactive medications.
  • History of substance abuse.

结局指标

主要结局

Use of fMRI as a tool

时间窗: one time 10 to 17 yrs. post-anesthesia

To evaluate the use of fMRI as a tool to investigate the functional consequence of exposure to general anesthetic medications during early brain development

次要结局

  • Brain activation patterns(one time 10 to 17 yrs. post-anesthesia)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Thomas Taghon

Attending Anesthesiologist

Nationwide Children's Hospital

研究点 (1)

Loading locations...

相似试验