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Status unknownNCT05661227Updated Dec 22, 2022

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

An interventional study of Dexmedetomidine and 0.9% Sodium chloride in Ischemic Reperfusion Injury, sponsored by Hebei Medical University Third Hospital. Status unknown at 2 sites in China. Open to participants aged 60 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-12-22.

Sponsored by Hebei Medical University Third Hospital · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Dec 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
60 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Ischemic Reperfusion Injury
03

In context

Reperfusion Injury

271 studies on the registry are indexed under Reperfusion Injury; 42 are open to participants now.

This study's planned enrollment of 120 is above the median of 61 across 215 interventional studies indexed under Reperfusion Injury.

Browse Reperfusion Injury studies →

Lead sponsor

Hebei Medical University Third Hospital is the lead sponsor of 27 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
60 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Care provider, Investigator, Outcomes assessor)
Enrollment
120 participants (estimated)

Study arms

  • Sham comparator
    C group

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

    Drug: 0.9% Sodium chloride

  • Experimental
    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

    Drug: Dexmedetomidine

  • Experimental
    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

    Device: Tourniquet(Early)

  • Experimental
    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

    Device: Tourniquet(Late)

Interventions

  • DrugDexmedetomidine

    Whether apply DEX or not

    Also known as: DEX

  • Drug0.9% Sodium chloride

    Whether apply DEX or not

    Also known as: NS

  • DeviceTourniquet(Early)

    Timing of tourniquet application

  • DeviceTourniquet(Late)

    Timing of tourniquet application

06

What researchers measure

Primary outcomes

  1. SOD

    Superoxide dismutase

    Time frame: Baseline to day2

  2. MDA

    Malonaldehyde

    Time frame: Baseline to day2

  3. IL-6

    Interleukin- 6

    Time frame: Baseline to day2

  4. TNF-α

    Tumor necrosis factor-α

    Time frame: Baseline to day2

  5. hs-Tn

    High sensitive troponin

    Time frame: Baseline to day2

  6. BDNF

    Brain-derived neurotrophic factor

    Time frame: Baseline to day2

Secondary outcomes

  1. HRV

    HeartRateVariability

    Time frame: Baseline to day2

  2. PRR

    Pulse Repetition Rate

    Time frame: Baseline to day2

  3. BP

    Blood Pressure(both systolic and diastolic blood pressure will be measured)

    Time frame: Baseline to day2

  4. SpO2

    Peripheral capillary oxygen saturation

    Time frame: Baseline to day2

  5. 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.)

    Time frame: Baseline to day2

  6. 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)

    Time frame: Baseline to day2

07

Study locations

2 of 2 sites recruiting
  • The Third Hospital of Hebei Medical University
    Shijiazhuang City, Hebei 050051, China
    Recruiting
  • The Third Hospital of Hebei Medical University
    Shijiazhuang City, Hebei 050051, China
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 22, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05661227
Lead sponsor
Hebei Medical University Third Hospital
Responsible party
Sponsor
First posted
Dec 22, 2022
Start date
Jan 1, 2023 (estimated)
Primary completion
Dec 31, 2023 (estimated)
Completion
Jun 30, 2024 (estimated)
Last update
Dec 22, 2022

Study contacts

Xin Liu
Contact
1536149525@qq.com
18810525281
PengChen Wang
study chair · Hebei Medical University Third Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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