The Effect of Caudal Epidural Injection Volume on Optic Nerve Sheath Diameter and Cerebral Oxygenation in Pediatric Cases
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Change in optic nerve sheath diameter
研究概览
简要总结
Caudal anesthesia is a commonly used neuraxial anesthesia method for children. Injection of a certain volume of fluid into the epidural space for cauda anesthesia may push some cerebrospinal fluid towards the head, which may lead to mild increase of pressures inside the head. Such mild changes are compensated well by healthy individuals and no clinical sequel is seen, however at-risk populations may be affected. We aim to see how different amounts of fluid injected into the epidural space may change two clinical parameters affected by intracranial pressure to determine if a lower volume is safer than a higher one.
详细描述
Caudal epidural injection of local anesthetic solution is a common neuraxial anesthesia technique that provides excellent peri-operative analgesia in children. Unfused sacral hiatus allows for easy and safe access into the epidural space. Anatomically, injection of a certain volume of fluid over the dural sac inside the closed spinal canal can push the cerebrospinal fluid cranially. This push may lead to increased intracranial pressure. We will measure two findings affected by intracranial pressure (optic nerve sheath diameter and cerebral oxygenation) and compare the effects of two different volumes of caudal injections on these measures.
Children with closed fontanelles and scheduled to undergo elective surgery, for which caudal anesthesia is an effective method for peri-operative analgesia, will be recruited for this study. Injection volume will be determined depending on the level of analgesia required for the surgical procedure. Ultrasonographic measurements of optic nerve sheath diameter and near-infrared spectrometry measurement of cerebral oxygenation will be taken before and after caudal anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Investigator, who will take and record the measurements, will not know about the volume of caudal injection. Another investigator will analyze the ultrasonography images without any knowledge of the patient or the intervention.
入排标准
- 年龄范围
- 12 Months 至 8 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ASA class 1 or 2
- •Scheduled for elective surgery suitable for caudal anesthesia
- •Parental/guardian consent for caudal anesthesia and measurements obtained
- •Closed fontanelles
排除标准
- •Open fontanelle
- •Parental/guardian refusal
- •Previous intracranial or ocular pathology
- •Coagulapathies
- •Variations in gross and ultrasonographic sacral anatomy
- •Block performence to end of surgery expected to last less than 30 minutes
- •Block volumes more than 30ml needed
- •Laparoscopic surgery
- •Need for long term analgesia with epidural catheter
研究组 & 干预措施
Low Volume
Caudal anesthesia will be performed with 0.8 ml/kg of the local anesthetic solution
干预措施: Caudal anesthesia (Procedure)
High Volume
Caudal anesthesia will be performed with 1.25 ml/kg of the local anesthetic solution
干预措施: Caudal anesthesia (Procedure)
结局指标
主要结局
Change in optic nerve sheath diameter
时间窗: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Difference in the percentage change of ultrasonographic measurement of optic nerve sheath diameter between groups
Change in cerebral oxygenation
时间窗: From before caudal injection to immediately, 10 min, 20 min and 30 min after.
Difference in the change in near-infrared spectrometry measurement of cerebral oxygenation between the groups
次要结局
- Variation in optic nerve sheath diameter(From before caudal injection to immediately, 10 min, 20 min and 30 min after.)
- Variation in cerebral oxygenation(From before caudal injection to immediately, 10 min, 20 min and 30 min after.)
研究者
Aybike Onur Gönen
Resident in Anesthesiology and Intensive Care
Istanbul University