: Effect of Epidural Injection of Normal Saline or Contrast Medium on Optic Nerve Sheath Diameter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- optic nerve sheath change during 4 time period
研究概览
简要总结
One method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. There is no study whether equal volume of contrast medium injection has any increasing effect of optic nerve sheath diameter.
This study is designed to measure the changes of optic nerve sheath diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was injected in epidural space.
详细描述
Previous study showed that different volume of injections (1.0 ml/kg vs. 1.5 ml/kg) during caudal anesthesia showed siginifiant increase of optic nerve sheath diameter in group of high volumes. Increase of ICP can result in harmful effect including reduced cerebral flow and oxygen saturation. Also, increase of ICP can cause headache, syncope and transient loss of visual acuity. The proven and valid method of measuring ICP indirectly is using optic nerve sheath diameter. This study was designed to examine the changes of optic nerve sheath diameter and cerebral oxygenation when equal volume of contrast medium or normal saline was injected in epidural space.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •lung cancer
- •liver cancer
- •stomach cancer
- •pancreas cancer
- •gallbladder
排除标准
- •coagulopathy
- •infection
- •previous spine fusion at thoracic level
- •previous brain lesion
研究组 & 干预措施
contrast group
injection of contrast medium 6 cc during thoracic epidural catheterization
干预措施: thoracic epidural catheterization (Other)
normal saline group
injection of normal saline 6 cc during thoracic epidural catheterization
干预措施: thoracic epidural catheterization (Other)
结局指标
主要结局
optic nerve sheath change during 4 time period
时间窗: Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention
optic nerve sheath change during 4 time period using ultrasound
次要结局
- cerebral oxygenation change during 4 time period(Baseline, 10 minutes, 20 minutes, 40 minutes after the completion of the intervention)
研究者
Ji Hee Hong
professor
Keimyung University Dongsan Medical Center