Comparison of the Effects of Anesthesia Techniques on Tissue Perfusion in Patients Undergoing Lower Extremity Surgery With Tourniquet Use
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Percentage AUC Loss During Tourniquet Inflation
研究概览
简要总结
This prospective, single-center observational study compares the effects of general anesthesia and spinal anesthesia on tissue perfusion in patients undergoing lower extremity surgery with tourniquet use. Tissue oxygenation in the limb distal to the tourniquet is monitored noninvasively using near-infrared spectroscopy (NIRS), and perfusion loss is quantified using an area-under-the-curve (AUC) approach. The primary objective is to evaluate whether spinal anesthesia better preserves distal tissue oxygenation during tourniquet inflation compared with general anesthesia. Secondary objectives are to assess reperfusion response after tourniquet release using changes in NIRS values at 20 minutes relative to baseline, the presence of early hyperemia (rSO₂ overshoot), and the association between tourniquet duration and perfusion loss. Additional exploratory analyses evaluate selected metabolic and inflammatory markers, including pH, lactate, and potassium.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years
- •Scheduled for elective lower extremity orthopedic surgery
- •ASA physical status I or II
- •Expected operation duration 30 to 120 minutes
- •Expected tourniquet duration 30 to 90 minutes
- •Informed about the anesthesia method and agreed to participate voluntarily
- •No contraindication to neuraxial block
排除标准
- •Refusal to participate
- •History of peripheral arterial disease, diabetic neuropathy, or advanced vascular insufficiency
- •Severe or uncontrolled systemic disease, including ASA III or higher
- •Coagulopathy, local infection, or contraindication to spinal anesthesia
- •Body mass index greater than 35 kg/m²
- •Pregnancy or impaired consciousness
- •Intraoperative hemodynamic instability or anticipated instability
- •Need for additional intraoperative sedative or analgesic medication
- •Inability to obtain adequate and reliable NIRS signal for technical reasons
研究组 & 干预措施
General Anesthesia Group
Patients undergoing lower extremity surgery under general anesthesia.
Spinal Anesthesia Group
Patients undergoing lower extremity surgery under spinal anesthesia.
结局指标
主要结局
Percentage AUC Loss During Tourniquet Inflation
时间窗: From tourniquet inflation to tourniquet deflation during surgery
Distal tissue oxygenation/perfusion loss measured by near-infrared spectroscopy (NIRS) as the percentage area-under-the-curve (AUC) loss of regional tissue oxygen saturation (rSO₂) during tourniquet inflation.
次要结局
- Reperfusion Response Assessed by ΔNIRS(Baseline to 20 minutes after tourniquet deflation)
- Association Between Tourniquet Duration and Percentage AUC Loss(Intraoperative period, during tourniquet use)
- Early Hyperemia (rSO₂ Overshoot)(Within 5 minutes after tourniquet deflation)
研究者
Taylan Kırdan
Resident doctor
Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization