Effect General and Regional Anesthesia on Glycocalyx
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Change in Perfused Boundary Region (PBR)
研究概览
简要总结
Observational study evaluating effect general or regional anaesthesia on glycocalyx by using perfused Boundary Region in sublingual microcirculation.
详细描述
Study II: Effect general and regional anaesthesia on GCX Hypothesis to be tested: Regional anaesthesia affects GCX less than general anaesthesia.
The aim of the study: Comparison of two anaesthesia techniques with respect to GCX.
Type of the study: Observational. Subjects: Adult patients ASA 2-3 undergoing elective total knee replacement surgery under general or regional anaesthesia. Sample size calculation (based on expected difference in PRB, alpha error I = 0,05 and study power = 0,99) = 52 patients. Investigators plan to enroll of 60 consecutive patients to reach 30 patients with each type of anaesthesia. Intervention: none. Data to be recorded and analysed: Demographics, ASA, physiologic functions (during surgery and 24 hours after surgery), fluids given, sublingual microcirculation by SDF imaging will be recorded at time points: before anaesthesia, 24 hours after anaesthesia, clinical outcome indicators, microcirculatory data and Perfused Boundary Region.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients ASA 2-3 undergoing elective total knee replacement surgery
排除标准
- 未提供
结局指标
主要结局
Change in Perfused Boundary Region (PBR)
时间窗: Change from baseline PBR at 24 hours after surgery
PBR is an indirect measure of glycocalyx thickness
次要结局
未报告次要终点
研究者
Vladimir Cerny
prof. Vladimir Cerny, MD, PhD, FCCM
University Hospital Hradec Kralove