Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery

Study Overview
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Brief Summary
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The purpose of this study is to observe whether the electroacupuncture (EA) preconditioning for five days before operation can improve the outcomes of patients with coronary heart disease undergoing geriatric non-cardiac surgery.

Detailed Description
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BACKGROUND: With the development of surgical techniques, more and more people with coronary heart disease underwent non-cardiac surgery, which include abdominal, urologic, orthopedic surgeries. Due to the vulnerable heart function, geriatric patients suffer high incidence of cardiovascular events during the peri-operative period. Some studies found that EA preconditioning have a protective effect for the patients underwent Cardiac surgery. But non one addresses the effects of EA preconditioning on the outcomes of the patients with coronary heart disease who undergo non-cardiac surgery. DESIGNING: The patients with coronary heart disease who will receive abdominal surgery will be randomly assigned into EA preconditioning group and control group. The patients in EA preconditioning group was treated at bilateral Neiguan (PC 6)，Lieque (LU 7) and Yunmen (LU 2) with electrical stimulation (5-30 Hz，2．34-6．24 mA，30 min) for 5 consecutive days before surgery．Before operation and before surgery, after surgery, 24h, 72h post surgery, all patients will be subjected to test the serum level of c-reactive protein and Troponin I. The EEG and heart ultrasonic exam will be used to evaluate the condition and function of heart before and after surgery.

Official Title
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Effects of Electroacupuncture Preconditioning on Outcomes of the Geriatric Patients With Coronary Heart Disease Undergoing Non-cardiac Surgery

Conditions
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Coronary Heart Disease

Intervention / Treatment
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* Device: EA preconditioning
* Device: sham EA preconditioning


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective abdominal surgery with coronary heart disease Exclusion Criteria: serious bradycardiac arrythmia

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EA preconditioning<br>electroacupuncture five days pre-operation | Device: EA preconditioning<br>* EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)with electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery<br>* Other names: Huantuo sdz-Ⅱ,Suzhou Medical Limit;|
| Sham Comparator: Sham EA preconditioning<br>Patients treated with sham EA preconditioning Intervention | Device: sham EA preconditioning<br>* Patients in Sham EA preconditioning group was treated at bilateral Neiguan(PC 6)，Lieque(LU 7)and Yunmen(LU 2)without electrical stimulation(5-30 Hz，2．34-6．24 mA，30 min)for 5 consecutive days before surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of myocardial ischemic injury markers,including serum level of c-reactive protein and Troponin I | to observe the change of the level of multiple myocardial ischemic injury markers at the different time points. | 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of ST segment of EEG at different time points |  | 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation | 
| Cardiac ultrasonic scan | be aware of cardiac function | five days pre-operation , five days post-operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroacupuncture, preconditioning, Non-cardiac surgery, Coronary heart disease