Ultrasonographic Assessment of Optic Nerve Sheath Diameter in Children Receiving Caudal Block
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The difference in the optic nerve sheath diameter between groups
研究概览
简要总结
The recent study revealed that high-volume caudal block caused reduction in cerebral blood flow velocity and cerebral oxygenation. It was supposed to be associated with increased intracranial pressure. 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 caudal block on intracranial pressure in pediatric patients undergoing urologic surgery. Eighty patients, aged 6 months to 4 years, receiving caudal block before urologic surgery will be divided into high dose group (n=40) and low dose group (n=40). Randomly selected patients of the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block. In contrast, patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block. The primary endpoint is the optic nerve sheath diameter after caudal block measured by optic nerve ultrasonography.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 6 Months 至 4 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pediatric patients
- •weighing less than 16 kg
- •who receive caudal block before urologic surgery
排除标准
- •Subjects are ineligible if they have contraindication for caudal block such as infection, coagulopathy, anomaly, or past medical history related to increased intracranial pressure
- •ophthalmic disease
- •expected operation time is less than 30 minutes
- •both parents are unable to communicate or speak Korean.
研究组 & 干预措施
low dose group
Patients in the low dose group are given 1.0 ml/kg of 0.15% ropivacaine for caudal block.
干预措施: 1.0 ml/kg of 0.15% ropivacaine (Drug)
high dose group
Patients in the high dose group are given 1.5 ml/kg of 0.15% ropivacaine for caudal block.
干预措施: 1.5 ml/kg of 0.15% ropivacaine (Drug)
结局指标
主要结局
The difference in the optic nerve sheath diameter between groups
时间窗: 1 day
次要结局
- The variation in the optic nerve sheath diameter before and after caudal block(30 minutes)
- the difference in the variation of the optic nerve sheath diameter between groups(30 minutes)