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

NCT ID: NCT05661227

Last Updated: 2022-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Ischemic Reperfusion Injury

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Caregivers Investigators Outcome Assessors

Study Groups

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C group

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

Group Type SHAM_COMPARATOR

0.9% Sodium chloride

Intervention Type DRUG

Whether apply DEX or not

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

Group Type EXPERIMENTAL

Dexmedetomidine

Intervention Type DRUG

Whether apply DEX or not

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

Group Type EXPERIMENTAL

Tourniquet(Early)

Intervention Type DEVICE

Timing of tourniquet application

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

Group Type EXPERIMENTAL

Tourniquet(Late)

Intervention Type DEVICE

Timing of tourniquet application

Interventions

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Dexmedetomidine

Whether apply DEX or not

Intervention Type DRUG

0.9% Sodium chloride

Whether apply DEX or not

Intervention Type DRUG

Tourniquet(Early)

Timing of tourniquet application

Intervention Type DEVICE

Tourniquet(Late)

Timing of tourniquet application

Intervention Type DEVICE

Other Intervention Names

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DEX NS

Eligibility Criteria

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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.
Minimum Eligible Age

60 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hebei Medical University Third Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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PengChen Wang

Role: STUDY_CHAIR

Hebei Medical University Third Hospital

Locations

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The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

The Third Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xin Liu

Role: CONTACT

Phone: 18810525281

Email: [email protected]

Facility Contacts

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Xin Liu

Role: primary

Other Identifiers

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Liuxin2022

Identifier Type: -

Identifier Source: org_study_id