The Effect of Continuous Epidural Analgesia on Intracranial Pressure by Measuring the Optic Nerve Sheath Diameter Using Ultrasound in Pediatric Patients
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- The difference in the optic nerve sheath diameter (ONSD) between groups
研究概览
简要总结
Ultrasonography of optic nerve sheath diameter shows a good level of diagnostic accuracy for detecting intracranial hypertension. The aim of this study is to evaluate the effect of continuous epidural block on intracranial pressure in pediatric patients undergoing osteotomy of lower extremity. Forty patients, aged 4 years to 13 years, receiving epidural analgesia before osteotomy will be divided into bolus group (n=30) and infusion group (n=30). Randomly selected patients of the bolus group are given 0.3 ml/kg bolus/hr of 0.15% ropivacaine for epidural analgesia. In contrast, patients in the infusion group are administered 0.3 ml/kg/hr 0.15% ropivacaine at a constant rate for epidural analgesia. The primary endpoint is the difference in the optic nerve sheath diameter after epidural analgesia measured by optic nerve ultrasonography between groups.
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
- Triple (Participant, Care Provider, Investigator)
盲法说明
Participants, care providers and investigators are blinded to group assignment.
入排标准
- 年龄范围
- 4 Years 至 13 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients from 4 to 13 years of age undergoing osteotomy of lower extremity
排除标准
- •Patients with contraindications to epidural analgesia (local infection, clotting disorders, anatomical abnormalities, sepsis, etc.)
- •Patients with symptoms or signs associated with a history of elevated intracranial pressure or elevated intracranial pressure
- •Patients with ophthalmic disease or surgery
- •The estimated operation time is less than 180 minutes.
- •All parents of the subject are foreigners or illiterate
研究组 & 干预措施
Bolus group
干预措施: bolus group and infusion group for epidural block (Procedure)
Infusion group
干预措施: bolus group and infusion group for epidural block (Procedure)
结局指标
主要结局
The difference in the optic nerve sheath diameter (ONSD) between groups
时间窗: 180 minutes after epidural block
The optic nerve sheath diameter measured by optic nerve ultrasonography
次要结局
- The difference in the number of patients whose ONSD values increased to more than 5.75 mm at each time point between the two groups(180 minutes after epidural block)