Mechanism of Cardiac and Cerebral Function Injury in Patients With Coronary Heart Disease Caused by Intraoperative Limb Ischemia-reperfusion and Perioperative Organ Function Protection Strategy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- IL-6
研究概览
简要总结
As a simple auxiliary tool for lower extremity orthopedic surgery, tourniquet can effectively reduce intraoperative bleeding and ensure the clarity of the operative field, effectively shorten the operation time and improve the operation efficiency. The extensive use of tourniquets in lower extremity surgery will not only cause local paralysis, pain and other complications, but also bring about postoperative complications such as large drainage volume and deep vein thrombosis. Recent studies have found that tourniquet induced ischemia-reperfusion injury not only affects the local tissue structure and function of skeletal muscle, but also causes reperfusion injury in distant organs (such as heart, lung and brain). Therefore, improving tourniquet ischemia-reperfusion injury after knee replacement is of great significance to improve the quality of life of patients during the perioperative period. Therefore, the aim of this study was to investigate the effects of dexmedetomidine and tourniquet pretreatment on myocardial injury and brain injury caused by lower extremity ischemia-reperfusion.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing TKA under general anesthesia
- •Voluntarily sign the informed consent
- •ASA Grade I to III
- •BMI 18-28 kg/m2
排除标准
- •Congenital heart disease or history of cardiac surgery, heart conduction disease, frequent ventricular/atrial premature beats, atrial fibrillation and other serious arrhythmias
- •Severe liver disease and kidney disease
- •Temporary and permanent pacemaker implantation
- •Patients with serious central nervous system diseases or serious mental disorders
- •Recent history of sedation, antidepressant or opioid use
- •Body mass index >35kg/m2
- •Participants in other clinical trials within 1 month prior to study enrollment.
研究组 & 干预措施
C group
Before induction of anesthesia, general anesthesia was performed after ultrasound-guided femoral nerve block
干预措施: 0.9% Sodium chloride (Drug)
DEX group
Before induction of anesthesia, general anesthesia was performed after ultrasound-guided femoral nerve block. Dexmedetomidine 0.8μg/kg was pumped intravenously for 10min 15min before induction of anesthesia, and then continued to be infused at 0.5μg/ (kg·h) until 30min before the end of surgery
干预措施: Dexmedetomidine (Drug)
ERIPC group
Before induction of anesthesia, ultrasound-guided femoral nerve block was performed, and then general anesthesia was performed. After induction of anesthesia, orthopedic tourniquet was tied and inflated to 200 mmHg(1 mmHg=0.133 kPa) for 5 min and deflated for 5 min, and three cycles were repeated
干预措施: Tourniquet(Early) (Device)
LRIPC group
An orthopedic pressure tourniquet was placed on the lower extremity 24 h before surgery and inflated to 200 mmHg for 5 min and deflated for 5 min. Three cycles were repeated
干预措施: Tourniquet(Late) (Device)
结局指标
主要结局
IL-6
时间窗: Baseline to day2
Interleukin- 6
SOD
时间窗: Baseline to day2
Superoxide dismutase
MDA
时间窗: Baseline to day2
Malonaldehyde
TNF-α
时间窗: Baseline to day2
Tumor necrosis factor-α
hs-Tn
时间窗: Baseline to day2
High sensitive troponin
BDNF
时间窗: Baseline to day2
Brain-derived neurotrophic factor
次要结局
- HRV(Baseline to day2)
- BP(Baseline to day2)
- MMSE(Baseline to day2)
- SpO2(Baseline to day2)
- VAS(Baseline to day2)
- PRR(Baseline to day2)