Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2011 by Xijing Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01507805
First received: December 13, 2011
Last updated: January 8, 2012
Last verified: February 2011
  Purpose

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.


Condition Intervention
Coronary Heart Disease
Device: EA preconditioning
Device: sham EA preconditioning

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Effects of Electroacupuncture Preconditioning on Outcomes of the Geriatric Patients With Coronary Heart Disease Undergoing Non-cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    to observe the change of the level of multiple myocardial ischemic injury markers at the different time points.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • Cardiac ultrasonic scan [ Time Frame: five days pre-operation , five days post-operation ] [ Designated as safety issue: No ]
    be aware of cardiac function


Estimated Enrollment: 300
Study Start Date: February 2011
Estimated Study Completion Date: January 2013
Estimated Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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

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

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective abdominal surgery with coronary heart disease

Exclusion Criteria:

  • serious bradycardiac arrythmia
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01507805

Locations
China, Shannxi
Xijing hospital Recruiting
Xi'an, Shannxi, China, 710032
Contact: Zhaoyang Xiao, Ph.D. , M.D.    86 15009250798    xiaozhaoy2006@hotmail.com   
Principal Investigator: Shaoyang Chen, M.D.         
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Shaoyang Chen, M.D. Xijing Hospital, the Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01507805     History of Changes
Other Study ID Numbers: csyxijing
Study First Received: December 13, 2011
Last Updated: January 8, 2012
Health Authority: China: National Natural Science Foundation

Keywords provided by Xijing Hospital:
Electroacupuncture
preconditioning
Non-cardiac surgery
Coronary heart disease

Additional relevant MeSH terms:
Heart Diseases
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 19, 2014