Ischemic Reperfusion Injury
Conditions
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.
Interventions
DRUGDexmedetomidine
Whether apply DEX or not
DRUG0.9% Sodium chloride
Whether apply DEX or not
DEVICETourniquet(Early)
Timing of tourniquet application
DEVICETourniquet(Late)
Timing of tourniquet application
Sponsors
Hebei Medical University Third Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BDNF | Baseline to day2 | Brain-derived neurotrophic factor |
| SOD | Baseline to day2 | Superoxide dismutase |
| MDA | Baseline to day2 | Malonaldehyde |
| IL-6 | Baseline to day2 | Interleukin- 6 |
| TNF-α | Baseline to day2 | Tumor necrosis factor-α |
| hs-Tn | Baseline to day2 | High sensitive troponin |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HRV | Baseline to day2 | HeartRateVariability |
| PRR | Baseline to day2 | Pulse Repetition Rate |
| BP | Baseline to day2 | Blood Pressure（both systolic and diastolic blood pressure will be measured） |
| 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.) |
| 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） |
Countries
China
Contacts
Primary ContactXin Liu
Outcome results
None listed