Mechanism of Cardiac and Cerebral Function Injury Caused by Intraoperative Limb Ischemia-reperfusion

Hebei Medical University Third Hospital

Status: Enrolling

Conditions: Ischemic Reperfusion Injury

Treatments: Device: Tourniquet(Early); Device: Tourniquet(Late); Drug: 0.9% Sodium chloride; Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT05661227

Liuxin2022

Details and patient eligibility

About

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.

Enrollment: 120 estimated patients

Sex: All

Ages: 60 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients undergoing TKA under general anesthesia
• Voluntarily sign the informed consent
• ASA Grade I to III
• BMI 18-28 kg/m2

Exclusion criteria

• 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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120 participants in 4 patient groups

C group

Sham Comparator group

Description:

Before induction of anesthesia, general anesthesia was performed after ultrasound-guided femoral nerve block

Treatment:

Drug: 0.9% Sodium chloride

DEX group

Experimental group

Description:

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

Treatment:

Drug: Dexmedetomidine

ERIPC group

Experimental group

Description:

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

Treatment:

Device: Tourniquet(Early)

LRIPC group

Experimental group

Description:

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

Treatment:

Device: Tourniquet(Late)