Mechanism of Cardiac and Cerebral Function Injury Caused by Intraoperative Limb Ischemia-reperfusion
- Conditions
- Ischemic Reperfusion Injury
- Interventions
- Registration Number
- NCT05661227
- Lead Sponsor
- Hebei Medical University Third Hospital
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 120
- Patients undergoing TKA under general anesthesia
- Voluntarily sign the informed consent
- ASA Grade I to III
- BMI 18-28 kg/m2
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description C group 0.9% Sodium chloride Before induction of anesthesia, general anesthesia was performed after ultrasound-guided femoral nerve block ERIPC group Tourniquet(Early) 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 LRIPC group Tourniquet(Late) 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 DEX group Dexmedetomidine 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
- Primary Outcome Measures
Name Time Method IL-6 Baseline to day2 Interleukin- 6
SOD Baseline to day2 Superoxide dismutase
MDA Baseline to day2 Malonaldehyde
TNF-α Baseline to day2 Tumor necrosis factor-α
hs-Tn Baseline to day2 High sensitive troponin
BDNF Baseline to day2 Brain-derived neurotrophic factor
- Secondary Outcome Measures
Name Time Method HRV Baseline to day2 HeartRateVariability
BP Baseline to day2 Blood Pressure（both systolic and diastolic blood pressure will be measured）
MMSE Baseline to day2 Mini-mental State Examination（The scale includes the following seven aspects: time orientation, place orientation, instant recall, attention and computational power, delayed memory, language, and whether to answer correctly or not. The test scores are closely related to the educational level. The normal threshold is more than 20 points, and the junior high school and above are more than 24 points）
SpO2 Baseline to day2 Peripheral capillary oxygen saturation
VAS Baseline to day2 Visual Analogue Scale/Score(Draw a 10cm horizontal line on the paper. One end of the horizontal line is 0, indicating no pain; the other end is 10, indicating severe pain; the middle part indicates pain. Different degrees of pain. Let the patient draw a mark on the horizontal line according to his own feelings to indicate the degree of pain.)
PRR Baseline to day2 Pulse Repetition Rate
Trial Locations
- Locations (1)
The Third Hospital of Hebei Medical University
🇨🇳Shijiazhuang City, Hebei, China