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Clinical Trials/NCT05661227
NCT05661227
Recruiting
Not Applicable

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

Hebei Medical University Third Hospital1 site in 1 country120 target enrollmentJanuary 1, 2023

Overview

Phase
Not Applicable
Intervention
0.9% Sodium chloride
Conditions
Ischemic Reperfusion Injury
Sponsor
Hebei Medical University Third Hospital
Enrollment
120
Locations
1
Primary Endpoint
IL-6
Status
Recruiting
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2023
End Date
June 30, 2024
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Hebei Medical University Third Hospital
Responsible Party
Sponsor

Eligibility Criteria

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.

Arms & Interventions

C group

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

Intervention: 0.9% Sodium chloride

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

Intervention: Dexmedetomidine

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

Intervention: Tourniquet(Early)

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

Intervention: Tourniquet(Late)

Outcomes

Primary Outcomes

IL-6

Time Frame: Baseline to day2

Interleukin- 6

SOD

Time Frame: Baseline to day2

Superoxide dismutase

MDA

Time Frame: Baseline to day2

Malonaldehyde

TNF-α

Time Frame: Baseline to day2

Tumor necrosis factor-α

hs-Tn

Time Frame: Baseline to day2

High sensitive troponin

BDNF

Time Frame: Baseline to day2

Brain-derived neurotrophic factor

Secondary Outcomes

  • HRV(Baseline to day2)
  • BP(Baseline to day2)
  • MMSE(Baseline to day2)
  • SpO2(Baseline to day2)
  • VAS(Baseline to day2)
  • PRR(Baseline to day2)

Study Sites (1)

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