The Effect of Leg Elevation on the Prevention of Intraoperative Hypotension During Shoulder Surgery in the Beach Chair Position
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Incidence of intraoperative hypotension
研究概览
简要总结
The aim of this study is to evaluate the effect of leg elevation on the prevention of intraoperative hypotension during shoulder surgery in the Beach-chair position. patients undergoing shoulder surgery in the Beach-chair position will be randomly assigned to Group L (with leg elevation) or Group C (no intervention). The primary outcome is the incidence of intraoperative hypotension (mean blood pressure < 60mmHg or systolic blood pressure < 80% of baseline). Secondary outcomes are the incidence of intraoperative cerebral desaturation (cerebral oxygen saturation < 80% of baseline, longer than 30 seconds), total amounts of administered inotropic agents, and systolic blood pressure, heart rate, and cerebral oxygen saturation at various time points.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •adult patients undergoing shoulder surgery in the beach chair position
排除标准
- •Patients with myocardial infarction
- •Patients with pacemaker
- •Patients with cerebrovascular disease
- •patients with arteriovenous fistula at the opposite arm
- •Patients with autonomic nerve disorders
- •Patients with hip or knee joint disorder limiting hip or knee flexion
- •BMI > 30 kg/m2
结局指标
主要结局
Incidence of intraoperative hypotension
时间窗: From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours)
Mean blood pressure \< 60 mmHg or systolic blood pressure \< 80% of baseline
次要结局
- Total amounts of administered inotropic agents(From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours))
- Peripheral oxygen saturation(before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning)
- Cerebral oxygen saturation(before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning)
- Systolic blood pressure(before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning)
- Incidence of intraoperative cerebral desaturation(From beach chair positioning to the end of surgery (average of 1 hour up to 2 hours))
- Heart rate(before induction(baseline) / before the Beach-chair positioning / 1,5,30 and 60 minutes after the Beach-chair positioning)
研究者
Jin-Tae Kim
Associate Professor
Seoul National University Hospital