Effect of Normal Saline Injection Volume on Epidural Pressure and Optic Nerve Sheath Diameter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 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
Valid method of indirect measurement of intracranial pressure is using optic nerve sheath diameter. Different volume of injection is known to affect the degree of increase of intracranial pressure.
This study is desinged to measure the changes of optic nerve sheath diameter and cerebral oxygenation when different volume of normal saline was injected.
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 different volume of normal saline was injected.
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 cancer
排除标准
- •coagulopathy
- •infection
- •previous spine fusion at thoracic level
- •previous brain lesion causing increased intracranial pressure
研究组 & 干预措施
injection of low volume of saline
low volume (5 cc) saline injection during thoracic epidural catheterization
干预措施: thoracic epidural catheterization (Procedure)
injection of intermediate volume of saline
intermediate volume (10 cc) saline injection during thoracic epidural catheterization
干预措施: thoracic epidural catheterization (Procedure)
injection of high volume of saline
high volume (20 cc) saline injection during thoracic epidural catheterization
干预措施: thoracic epidural catheterization (Procedure)
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