Clinical trial NCT05661227: Mechanism of Cardiac and Cerebral Function Injury Caused by Intraoperative Limb Ischemia-reperfusion
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Ischemic Reperfusion Injury
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2022-12-22
Enrollment: 120
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: SOD
timeFrame: Baseline to day2
measure: MDA
timeFrame: Baseline to day2
measure: IL-6
timeFrame: Baseline to day2
measure: TNF-α
timeFrame: Baseline to day2
measure: hs-Tn
timeFrame: Baseline to day2
measure: BDNF
timeFrame: Baseline to day2
Secondary outcomes:
measure: HRV
timeFrame: Baseline to day2
measure: PRR
timeFrame: Baseline to day2
measure: BP
timeFrame: Baseline to day2
measure: SpO2
timeFrame: Baseline to day2
measure: VAS
timeFrame: Baseline to day2
measure: MMSE
timeFrame: Baseline to day2
Other outcomes:
Locations:
city: Shijiazhuang City
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
city: Shijiazhuang City
country: China
facility: The Third Hospital of Hebei Medical University
state: Hebei
Study officials:
affiliation: Hebei Medical University Third Hospital
name: PengChen Wang
role: STUDY_CHAIR
References: