An interventional study of Dexmedetomidine and 0.9% Sodium chloride in Ischemic Reperfusion Injury, sponsored by Hebei Medical University Third Hospital. Status unknown at 2 sites in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Hebei Medical University Third Hospital · Not applicable, Interventional, and Prevention
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.
271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.
This study's planned enrollment of 120 is above the median of 61 across 215 interventional studies indexed under Reperfusion Injury.
Browse Reperfusion Injury studies →Hebei Medical University Third Hospital is the lead sponsor of 27 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Before induction of anesthesia, general anesthesia was performed after ultrasound-guided femoral nerve block
Drug: 0.9% Sodium chloride
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
Drug: Dexmedetomidine
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
Device: Tourniquet(Early)
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
Device: Tourniquet(Late)
Whether apply DEX or not
Also known as: DEX
Whether apply DEX or not
Also known as: NS
Timing of tourniquet application
Timing of tourniquet application
SOD
Superoxide dismutase
Time frame: Baseline to day2
MDA
Malonaldehyde
Time frame: Baseline to day2
IL-6
Interleukin- 6
Time frame: Baseline to day2
TNF-α
Tumor necrosis factor-α
Time frame: Baseline to day2
hs-Tn
High sensitive troponin
Time frame: Baseline to day2
BDNF
Brain-derived neurotrophic factor
Time frame: Baseline to day2
HRV
HeartRateVariability
Time frame: Baseline to day2
PRR
Pulse Repetition Rate
Time frame: Baseline to day2
BP
Blood Pressure(both systolic and diastolic blood pressure will be measured)
Time frame: Baseline to day2
SpO2
Peripheral capillary oxygen saturation
Time frame: Baseline to day2
VAS
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.)
Time frame: Baseline to day2
MMSE
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)
Time frame: Baseline to day2
Plan to share: No
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Hebei Medical University Third Hospital