Comparison of Optic Nerve Sheath Diameter in Children Receiving Caudal Block According to Anesthetic Agents: Total Intravenous Anesthesia vs. Volatile Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- ONSD
研究概览
简要总结
Caudal block is commonly used for postoperative analgesia in paediatric patients. A higher volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only increase the level of cranial spread but also provide better quality and longer duration of analgesia in comparison with the conventional volume (1.0 ml/kg). However, caudal block with a high volume of local anaesthetic can increase intracranial pressure (ICP). Previous studies have shown that propofol anesthesia lowers ICP when compared with volatile anesthesia. Therefore, this study was designed to test if propofol can reduce the magnitude of ICP increase following caudal block when compared with a volatile anesthetic, sevoflurane. There is increasing evidence that optic nerve sheath diameter (ONSD) measured by ultrasonography correlates with degree of ICP and is able to detect intracranial hypertension. Therefore, ONSD will be measured as a surrogate of ICP.
详细描述
Equal number of patients are randomly assigned to the P or S group. The participants in the P and S group are anesthetized with propofol and sevoflurane, respectively. Irrespective of assigned group, all participants receive caudal block with 1.5 ml/kg of 0.15% ropivacaine (up to 30 ml per individual participant). All anesthetic procedures except for main anesthetic agent are the same in all participants. ONSD is measured at the following time points: before (T0), immediately after (T1), and 10 min (T2) and 30 min(T3) after caudal block. Two measurements of each optic nerve sheath are acquired in each eye. The mean value of the four measurements is considered as the ONSD at each time point.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
Anesthesia machine and infusion pumps are shielded from assessors who measure ONSD.
入排标准
- 年龄范围
- 3 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Among children undergoing urological surgery, patients, 36 to 72-months-old
- •Body weight less than 20 kg (The limit on body weight is set because the maximum volume of local anaesthetic for caudal block in children is restricted to 30 ml.)
- •Treatment plan for caudal block for analgesia, are enrolled.
排除标准
- •Symptoms or signs of spinal anomalies or infection at the sacral region
- •Coagulopathy
- •Increased ICP
- •Ophthalmic diseases
- •History of increased ICP
研究组 & 干预措施
group P
The participants in the group P are anesthetized with propofol.
干预措施: Propofol (Drug)
group S
The participants in the group S are anesthetized with sevoflurane.
干预措施: Sevoflurane (Drug)
结局指标
主要结局
ONSD
时间窗: 30 minutes (T3) after caudal block.
ONSD is a surrogate for ICP. ONSD was measured by transorbital sonography. Transorbital sonography is performed using a linear 6-13 Hz probe. After applying a thick layer of sterile coupling gel on the closed upper eyelid, the probe is placed gently without exerting pressure. Axial images of the orbit are acquired in the plane of the optic nerve, and ONSD is measured 3mm posterior to the optic nerve head as described previously.
次要结局
- The variables affecting ICP : Heart rate (beats per minute)(30 minutes (T3) after caudal block.)
- The variables affecting ICP : Peak inspiratory pressure (mmHg)(30 minutes (T3) after caudal block.)
- The variables affecting ICP : Mean arterial pressure (mmHg)(30 minutes (T3) after caudal block.)
- The variables affecting ICP : Estimated propofol effect-site concentration (μg/ml)(30 minutes (T3) after caudal block.)
- The variables affecting ICP : End-tidal carbon dioxide partial pressure (mmHg)(30 minutes (T3) after caudal block.)
- The variables affecting ICP : End-tidal sevoflurane concentration (volume %)(30 minutes (T3) after caudal block.)
- The variables affecting ICP : Body temperature (℃)(30 minutes (T3) after caudal block.)