Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery

Not Applicable

• Conditions: Coronary Heart Disease
• Interventions: Device: EA preconditioning; Device: sham EA preconditioning

• Registration Number: NCT01507805
• Lead Sponsor: Xijing Hospital

Brief Summary

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

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.

Study Timeline

• Status Verified: 2011-02
• Study Start: 2011-02
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-01-08
• Last Update Submitted: 2012-01-08
• Study First Posted: 2012-01-11
• Last Update Posted: 2012-01-11
• Primary Completion: 2012-06
• Study Completion: 2013-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• elective abdominal surgery with coronary heart disease

Exclusion Criteria

• serious bradycardiac arrythmia

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EA preconditioning	EA preconditioning	electroacupuncture five days pre-operation
Sham EA preconditioning	sham EA preconditioning	Patients treated with sham EA preconditioning Intervention

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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	five days pre-operation , five days post-operation	be aware of cardiac function

Trial Locations

Locations (1)

Xijing hospital; 🇨🇳 Xi'an, Shannxi, China