Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery

NCT ID: NCT01507805

Last Updated: 2012-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-02-28

Study Completion Date

2013-01-31

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.

Conditions

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Coronary Heart Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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EA preconditioning

electroacupuncture five days pre-operation

Group Type EXPERIMENTAL

EA preconditioning

Intervention Type DEVICE

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 treated with sham EA preconditioning Intervention

Group Type SHAM_COMPARATOR

sham EA preconditioning

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

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

Intervention Type DEVICE

Other Intervention Names

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Huantuo sdz-Ⅱ,Suzhou Medical Limit

Eligibility Criteria

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Inclusion Criteria

* elective abdominal surgery with coronary heart disease

Exclusion Criteria

* serious bradycardiac arrythmia
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Xijing Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Shaoyang Chen, M.D.

Role: PRINCIPAL_INVESTIGATOR

Xijing Hospital, the Fourth Military Medical University

Locations

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Xijing hospital

Xi'an, Shannxi, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Zhaoyang Xiao, Ph.D., M.D.

Role: primary

86 15009250798

Other Identifiers

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csyxijing

Identifier Type: -

Identifier Source: org_study_id

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