Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery

January 8, 2012 updated by: Xijing Hospital

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shannxi
      • Xi'an, Shannxi, China, 710032
        • Recruiting
        • Xijing Hospital
        • Contact:
        • Principal Investigator:
          • Shaoyang Chen, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective abdominal surgery with coronary heart disease

Exclusion Criteria:

  • serious bradycardiac arrythmia

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EA preconditioning
electroacupuncture five days pre-operation
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
Other Names:
  • Huantuo sdz-Ⅱ,Suzhou Medical Limit
Sham Comparator: Sham EA preconditioning
Patients treated with sham EA preconditioning Intervention
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

What is the study measuring?

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
Time Frame: 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.
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
Time Frame: 10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation
10 minutes before EA, 10 minutes pre-operation,the day of post-operation, 24hours post-operation, 72 hours post-operation
Cardiac ultrasonic scan
Time Frame: five days pre-operation , five days post-operation
be aware of cardiac function
five days pre-operation , five days post-operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Xijing Hospital

Investigators

  • Principal Investigator: Shaoyang Chen, M.D., Xijing Hospital, the Fourth Military Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Anticipated)

June 1, 2012

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

January 8, 2012

First Posted (Estimate)

January 11, 2012

Study Record Updates

Last Update Posted (Estimate)

January 11, 2012

Last Update Submitted That Met QC Criteria

January 8, 2012

Last Verified

February 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • csyxijing

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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