Ischemic Reperfusion InjuryNCT05661227
Mechanism of Cardiac and Cerebral Function Injury Caused by Intraoperative Limb Ischemia-reperfusion
A study testing Dexmedetomidine, 0.9% Sodium chloride and Tourniquet(Early) in people with Ischemic Reperfusion Injury, run by Hebei Medical University Third Hospital at 2 sites in China.
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. Read more about this study
- Who is it for?
- Ages 60 to 80 years
- Conditions the study is for
- Ischemic Reperfusion Injury
- What is being tested?
- Dexmedetomidine, 0.9% Sodium chloride and Tourniquet(Early)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jan 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing TKA under general anesthesia
- Voluntarily sign the informed consent
- ASA Grade I to III
- BMI 18-28 kg/m2
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
Xin Liu, 18332188600, 1536149525@qq.com
- Recruiting
The Third Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050051
About this study
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
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
- Being tested
- Dexmedetomidine, 0.9% Sodium chloride, Tourniquet(Early), Tourniquet(Late)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Also called DEX
Whether apply DEX or not
0.9% Sodium chlorideDrug
Also called NS
Whether apply DEX or not
Tourniquet(Early)Device
Timing of tourniquet application
Tourniquet(Late)Device
Timing of tourniquet application
| Study group | Role | What they receive |
|---|---|---|
| C group | Sham comparator | Before induction of anesthesia, general anesthesia was performed after ultrasound-guided femoral nerve block Receives: 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 Receives: 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 Receives: 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 Receives: Device: Tourniquet(Late) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SOD
Superoxide dismutase
Measured: Baseline to day2
MDA
Malonaldehyde
Measured: Baseline to day2
IL-6
Interleukin- 6
Measured: Baseline to day2
TNF-α
Tumor necrosis factor-α
Measured: Baseline to day2
hs-Tn
High sensitive troponin
Measured: Baseline to day2
BDNF
Brain-derived neurotrophic factor
Measured: Baseline to day2
Secondary outcomes (6)
HRV
HeartRateVariability
Measured: Baseline to day2
PRR
Pulse Repetition Rate
Measured: Baseline to day2
BP
Blood Pressure（both systolic and diastolic blood pressure will be measured）
Measured: Baseline to day2
SpO2
Peripheral capillary oxygen saturation
Measured: Baseline to day2
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.)
Measured: Baseline to day2
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）
Measured: Baseline to day2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2022
- Study start1 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Reperfusion InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Third Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PengChen Wang, Study chair, Hebei Medical University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05661227
- Sponsor's protocol ID
- Liuxin2022
- Status last verified
- Dec 2022
- First submitted
- 17 Nov 2022
- Last updated
- 22 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05661227
- Acronym / sponsor ID
- Liuxin2022
- Conditions
- Ischemic Reperfusion Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hebei Medical University Third HospitalUniversity, hospital or other
- Study start
- 1 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 22 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| C group | Sham comparator | Drug: 0.9% Sodium chlorideBefore induction of anesthesia, general anesthesia was performed after ultrasound-guided femoral nerve block |
| DEX group | Experimental | Drug: DexmedetomidineBefore 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 |
| ERIPC group | Experimental | Device: Tourniquet(Early)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 |
| LRIPC group | Experimental | Device: Tourniquet(Late)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 |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients undergoing TKA under general anesthesia
- Voluntarily sign the informed consent
- ASA Grade I to III
- BMI 18-28 kg/m2
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DexmedetomidineAlso: DEXWhether apply DEX or not | Drug | DEX group |
| 0.9% Sodium chlorideAlso: NSWhether apply DEX or not | Drug | C group |
| Tourniquet(Early)Timing of tourniquet application | Device | ERIPC group |
| Tourniquet(Late)Timing of tourniquet application | Device | LRIPC group |
Primary outcome
SOD
Time frame: Baseline to day2
Superoxide dismutase
MDA
Time frame: Baseline to day2
Malonaldehyde
IL-6
Time frame: Baseline to day2
Interleukin- 6
TNF-α
Time frame: Baseline to day2
Tumor necrosis factor-α
hs-Tn
Time frame: Baseline to day2
High sensitive troponin
BDNF
Time frame: Baseline to day2
Brain-derived neurotrophic factor
6 secondary outcomes
HRV
Time frame: Baseline to day2
PRR
Time frame: Baseline to day2
BP
Time frame: Baseline to day2
SpO2
Time frame: Baseline to day2
VAS
Time frame: Baseline to day2
MMSE
Time frame: Baseline to day2
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PengChen Wang study chair
Hebei Medical University Third Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine, 0.9% Sodium chloride and Tourniquet(Early) in people with Ischemic Reperfusion Injury, run by Hebei Medical University Third Hospital at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Liu (18810525281, 1536149525@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SOD (time frame: Baseline to day2). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2022.