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

Ischemic Reperfusion Injury Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05661227
• Other study ID #: Liuxin2022
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: June 30, 2024

Study information

• Verified date: December 2022
• Source: Hebei Medical University Third Hospital
• Contact: Xin Liu
• Phone: 18810525281
• Email: 1536149525[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Ischemic Reperfusion Injury
• Reperfusion Injury
• Wounds and Injuries

Intervention

Drug:
• Dexmedetomidine
Whether apply DEX or not
• 0.9% Sodium chloride
Whether apply DEX or not

Device:
• Tourniquet(Early)
Timing of tourniquet application
• Tourniquet(Late)
Timing of tourniquet application

Locations

Country	Name	City	State
China	The Third Hospital of Hebei Medical University	Shijiazhuang City	Hebei
China	The Third Hospital of Hebei Medical University	Shijiazhuang City	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SOD	Superoxide dismutase	Baseline to day2
Primary	MDA	Malonaldehyde	Baseline to day2
Primary	IL-6	Interleukin- 6	Baseline to day2
Primary	TNF-a	Tumor necrosis factor-a	Baseline to day2
Primary	hs-Tn	High sensitive troponin	Baseline to day2
Primary	BDNF	Brain-derived neurotrophic factor	Baseline to day2
Secondary	HRV	HeartRateVariability	Baseline to day2
Secondary	PRR	Pulse Repetition Rate	Baseline to day2
Secondary	BP	Blood Pressure(both systolic and diastolic blood pressure will be measured)	Baseline to day2
Secondary	SpO2	Peripheral capillary oxygen saturation	Baseline to day2
Secondary	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.)	Baseline to day2
Secondary	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)	Baseline to day2