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

NCT05661227 | Unknown

• 1 other identifier: Liuxin2022
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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.

Conditions

Ischemic Reperfusion Injury

Outcome Measures

Primary Outcomes (6)

• SOD

  Superoxide dismutase

  Baseline to day2

• MDA

  Malonaldehyde

  Baseline to day2

• IL-6

  Interleukin- 6

  Baseline to day2

• TNF-α

  Tumor necrosis factor-α

  Baseline to day2

• hs-Tn

  High sensitive troponin

  Baseline to day2

• BDNF

  Brain-derived neurotrophic factor

  Baseline to day2

Secondary Outcomes (6)

• HRV

  Baseline to day2

• PRR

  Baseline to day2

• BP

  Baseline to day2

• SpO2

  Baseline to day2

• VAS

  Baseline to day2

Study Arms (4)

C group

SHAM COMPARATOR

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

Drug: 0.9% Sodium chloride

DEX group

EXPERIMENTAL

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

ERIPC group

EXPERIMENTAL

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)

LRIPC group

EXPERIMENTAL

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)

Interventions

Dexmedetomidine DRUG

Whether apply DEX or not

Also known as: DEX

DEX group

0.9% Sodium chloride DRUG

Whether apply DEX or not

Also known as: NS

C group

Tourniquet(Early) DEVICE

Timing of tourniquet application

ERIPC group

Tourniquet(Late) DEVICE

Timing of tourniquet application

LRIPC group

Eligibility Criteria

• Age: 60 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing TKA under general anesthesia
• Voluntarily sign the informed consent
• ASA Grade I to III
• BMI 18-28 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hebei Medical University Third Hospital: lead

Study Sites (2)

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

RECRUITING

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050051, China

RECRUITING

MeSH Terms

Interventions

Dexmedetomidine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• PengChen Wang

  Hebei Medical University Third Hospital

  STUDY CHAIR

Central Study Contacts

Xin Liu

CONTACT

18810525281; 1536149525@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2022
• First Posted: December 22, 2022
• Study Start: January 1, 2023
• Primary Completion: December 31, 2023
• Study Completion: June 30, 2024
• Last Updated: December 22, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)