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

Primary Purpose

Ischemic Reperfusion Injury

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Dexmedetomidine
0.9% Sodium chloride
Tourniquet(Early)
Tourniquet(Late)
Sponsored by
Hebei Medical University Third Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Ischemic Reperfusion Injury

Eligibility Criteria

60 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Third Hospital of Hebei Medical UniversityRecruiting
  • The Third Hospital of Hebei Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Sham Comparator

Experimental

Experimental

Experimental

Arm Label

C group

DEX group

ERIPC group

LRIPC group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

SOD
Superoxide dismutase
MDA
Malonaldehyde
IL-6
Interleukin- 6
TNF-α
Tumor necrosis factor-α
hs-Tn
High sensitive troponin
BDNF
Brain-derived neurotrophic factor

Secondary Outcome Measures

HRV
HeartRateVariability
PRR
Pulse Repetition Rate
BP
Blood Pressure(both systolic and diastolic blood pressure will be measured)
SpO2
Peripheral capillary oxygen saturation
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.)
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)

Full Information

First Posted
November 17, 2022
Last Updated
December 13, 2022
Sponsor
Hebei Medical University Third Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05661227
Brief Title
Mechanism of Cardiac and Cerebral Function Injury Caused by Intraoperative Limb Ischemia-reperfusion
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Reperfusion Injury

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
C group
Arm Type
Sham Comparator
Arm Description
Before induction of anesthesia, general anesthesia was performed after ultrasound-guided femoral nerve block
Arm Title
DEX group
Arm Type
Experimental
Arm Description
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
Arm Title
ERIPC group
Arm Type
Experimental
Arm Description
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
Arm Title
LRIPC group
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexmedetomidine
Other Intervention Name(s)
DEX
Intervention Description
Whether apply DEX or not
Intervention Type
Drug
Intervention Name(s)
0.9% Sodium chloride
Other Intervention Name(s)
NS
Intervention Description
Whether apply DEX or not
Intervention Type
Device
Intervention Name(s)
Tourniquet(Early)
Intervention Description
Timing of tourniquet application
Intervention Type
Device
Intervention Name(s)
Tourniquet(Late)
Intervention Description
Timing of tourniquet application
Primary Outcome Measure Information:
Title
SOD
Description
Superoxide dismutase
Time Frame
Baseline to day2
Title
MDA
Description
Malonaldehyde
Time Frame
Baseline to day2
Title
IL-6
Description
Interleukin- 6
Time Frame
Baseline to day2
Title
TNF-α
Description
Tumor necrosis factor-α
Time Frame
Baseline to day2
Title
hs-Tn
Description
High sensitive troponin
Time Frame
Baseline to day2
Title
BDNF
Description
Brain-derived neurotrophic factor
Time Frame
Baseline to day2
Secondary Outcome Measure Information:
Title
HRV
Description
HeartRateVariability
Time Frame
Baseline to day2
Title
PRR
Description
Pulse Repetition Rate
Time Frame
Baseline to day2
Title
BP
Description
Blood Pressure(both systolic and diastolic blood pressure will be measured)
Time Frame
Baseline to day2
Title
SpO2
Description
Peripheral capillary oxygen saturation
Time Frame
Baseline to day2
Title
VAS
Description
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
Title
MMSE
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xin Liu
Phone
18810525281
Email
1536149525@qq.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
PengChen Wang
Organizational Affiliation
Hebei Medical University Third Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang City
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xin Liu
Phone
18332188600
Email
1536149525@qq.com
Facility Name
The Third Hospital of Hebei Medical University
City
Shijiazhuang City
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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