Clinical trial NCT01507805: Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery
Official title: Effects of Electroacupuncture Preconditioning on Outcomes of the Geriatric Patients With Coronary Heart Disease Undergoing Non-cardiac Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Heart Disease
Keywords: Electroacupuncture
preconditioning
Non-cardiac surgery
Coronary heart disease
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2012-01-11
Enrollment: 300
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: Inclusion Criteria:

* elective abdominal surgery with coronary heart disease

Exclusion Criteria:

* serious bradycardiac arrythmia

Primary outcomes:
measure: The change of myocardial ischemic injury markers,including serum level of c-reactive protein and Troponin I
timeFrame: 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation
Secondary outcomes:
measure: The change of ST segment of EEG at different time points
timeFrame: 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation
measure: Cardiac ultrasonic scan
timeFrame: five days pre-operation , five days post-operation
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing hospital
state: Shannxi
Study officials:
affiliation: Xijing Hospital, the Fourth Military Medical University
name: Shaoyang Chen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: