Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery

Coronary Heart Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01507805
• Other study ID #: csyxijing
• Status: Recruiting
• Phase: N/A
• First received: December 13, 2011
• Last updated: January 8, 2012
• Start date: February 2011
• Est. completion date: January 2013

Study information

• Verified date: February 2011
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: National Natural Science Foundation
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: January 2013
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• elective abdominal surgery with coronary heart disease

Exclusion Criteria:

• serious bradycardiac arrythmia

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Heart Diseases
• Myocardial Ischemia

Intervention

Device:
• EA preconditioning
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
• sham EA preconditioning
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

Locations

Country	Name	City	State
China	Xijing hospital	Xi'an	Shannxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Cardiac ultrasonic scan	be aware of cardiac function	five days pre-operation , five days post-operation	No