Effect of Arterial Pressure Regulation on Optic Nerve Sheath Diameter During Robot Assisted Laparoscopic Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- optic nerve sheath diameter change among 4 time period
研究概览
简要总结
Intracranial pressure is known to increase during robot-assisted laparoscopic radical prostatectomy (RALRP) due to steep trendelenberg position. Measurement of optic nerve sheath diameter (ONSD) is a indirect method which can assess the degree of intracranial pressure.
This study is designed to measure the ONSD during RALRP under regulation of arterial pressure.
详细描述
During last decades, RALRP has been advocated due to the advantages of short hospital stay, reduced blood loss during surgery, less postoperative pain and complication. During RALRP, steep trendelenberg postion and pneumoperitoneum are required essentially, and this is for the acquisition of adequite surgical field. However, such position and pneumoperitoneum can result in harmful hemodynamic change. Previous study demonstrated that patients of RALRP showed 12.5% increase of ONSD.
The relationship of ONSD and increase of intracranial pressure has been proved previously through many studies. Recent meta analysis showed that ONSD measurement for the monitor of ICP demonstrated that sensitivity 0.9, specificity 0.85 and ROC cuve 0.983.
In addition, increase of ONSD during RALRP can be affected by the degree of arterial pressure and end tidal CO2 increase.
This study is designed to see the effect of arterial pressure regulation on the increase of ONSD
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Prostate cancer receiving RALRP
排除标准
- •intracranial tumor
- •previous disease elevating intracranial pressure
结局指标
主要结局
optic nerve sheath diameter change among 4 time period
时间窗: Baseline, 1 hour, 2 hours, 2.5 hours after completion of the intervention
optice nerve sheath diameter change among 4 time period
次要结局
未报告次要终点
研究者
Ji Hee Hong
Principal Investigator
Keimyung University Dongsan Medical Center