Gradual Deflation of Thigh Tourniquet for Attenuation of Hemodynamic Post-tourniquet Response in Old Patients :Randomized Control Study
试验速览
- 阶段
- 不适用
- 入组人数
- 81
- 试验地点
- 1
- 主要终点
- mean arterial blood pressure
研究概览
简要总结
Deflation of the pneumatic tourniquet used in lower limb surgery is usually associated with hemodynamic instability, metabolic and respiratory changes. These changes are usually tolerated by young, healthy patients; However, these complications are risky for elderly and cardiac patients. The aim of this study is to assess the effect of gradual deflation of thigh tourniquet on the hemodynamics and arterial blood gases compared to the usual practice
详细描述
Pneumatic tourniquet will be applied on the mid- thigh with cuff pressure of 350 mm Hg. After the end of surgery, the lower limb will be elevated at 45-degree and the patients will randomized into one of the three groups:
G 50 (n=30) : The tourniquet cuff pressure will be deflated gradually by 50 mm Hg every 2 minutes till complete deflation.
G 100 (n=30): The tourniquet cuff pressure will be deflated gradually by 100 mm Hg every 2 minutes till complete deflation.
G 0 (n=30): The tourniquet cuff will be released till complete deflation. If hypotension is observed during the procedure, it will be managed by 10 mg ephedrine.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 50 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •scheduled for elective orthopedic lower limb surgery under pneumatic tourniquet
排除标准
- •BMI ≥35Kg/ m2
- •patients with unstable angina, left ventricular dysfunction , cerebrovascular disease ,bleeding disorders
- •contraindication to tourniquet insertion
- •patients requiring massive intraoperative blood transfusion (Blood loss more than 50% of the patients' blood volume (70 ml/Kg) ).
结局指标
主要结局
mean arterial blood pressure
时间窗: 15 minutes after start of deflation of cuff
The lowest mean arterial blood pressure during a 15-minute period after starting deflation of the tourniquet.
次要结局
- hypotension(15 minutes after start of deflation of cuff)
- cardiac output(15 minutes after start of deflation of cuff)
研究者
Yasmin Hassab elnaby
Principal investigator
Cairo University