The Efficacy of Using Lower Tourniquet Pressure During Total Knee Arthroplasty: Comparison With Conventional Tourniquet Pressure Group
试验速览
- 阶段
- 不适用
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Acquisition of bloodless surgical field just after skin incision
研究概览
简要总结
This study aims to determine whether the lower tourniquet pressure, which is set by adding 120mmHg (millimeter of mercury) on the systolic blood pressure just before tourniquet inflation, are efficient and safe during total knee arthroplasty, compared with the conventional tourniquet pressure: 150mmHg above the systolic blood pressure before tourniquet inflation.
详细描述
We will compare the two groups of patients undergoing total knee arthroplasty, which the tourniquet pressure will be set differently: systolic blood pressure plus 120mmHg vs. systolic blood pressure plus 150mmHg, the conventional method, in terms of efficacy and safety.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients undergoing total knee arthroplasty
排除标准
- •Systolic blood pressure measured at ward > 200mmHg
- •Thigh circumference > 78cm
- •Anesthesia other than spinal anesthesia
- •Simultaneous bilateral total knee arthroplasty
- •The patients who disagreed the enrollment of this study
研究组 & 干预措施
Conventional tourniquet pressure
The patients in this group will undertake total knee arthroplasty under conventional tourniquet pressure, which will be set as the pressure added by 150mmHg on the last systolic blood pressure just before tourniquet inflation.
干预措施: Conventional tourniquet pressure (Procedure)
Low tourniquet pressure
The patients in this group will undertake total knee arthroplasty under low tourniquet pressure, which will be set as the pressure added by 120mmHg on the last systolic blood pressure just before tourniquet inflation.
干预措施: Low tourniquet pressure (Procedure)
结局指标
主要结局
Acquisition of bloodless surgical field just after skin incision
时间窗: just after skin incision during operation
Dichotomous variable determined during operation by operator (Yes or No)
次要结局
- symptomatic venous-thromboembolism(within 7 days after surgery)
- Failure of acquiring bloodless surgical field during operation(after skin incision through the point of tourniquet deflation)
- Increasement of tourniquet pressure to acquire bloodless surgical field(after skin incision though the point of tourniquet deflation)
- Thigh pain on the site of tourniquet application(postoperative 2nd day)
- Knee pain(postoperative 2nd day)
- Skin problem on the site of tourniquet application(posteoperative 2nd day)
- Nerve palsy(within 7 days after surgery)