Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery
Primary Purpose
Coronary Heart Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EA preconditioning
sham EA preconditioning
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Heart Disease focused on measuring Electroacupuncture, preconditioning, Non-cardiac surgery, Coronary heart disease
Eligibility Criteria
Inclusion Criteria:
- elective abdominal surgery with coronary heart disease
Exclusion Criteria:
- serious bradycardiac arrythmia
Sites / Locations
- Xijing hospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
EA preconditioning
Sham EA preconditioning
Arm Description
electroacupuncture five days pre-operation
Patients treated with sham EA preconditioning Intervention
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
The change of ST segment of EEG at different time points
Cardiac ultrasonic scan
be aware of cardiac function
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01507805
Brief Title
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
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Unknown status
Study Start Date
February 2011 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
January 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
Electroacupuncture, preconditioning, Non-cardiac surgery, Coronary heart disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
EA preconditioning
Arm Type
Experimental
Arm Description
electroacupuncture five days pre-operation
Arm Title
Sham EA preconditioning
Arm Type
Sham Comparator
Arm Description
Patients treated with sham EA preconditioning Intervention
Intervention Type
Device
Intervention Name(s)
EA preconditioning
Other Intervention Name(s)
Huantuo sdz-Ⅱ,Suzhou Medical Limit
Intervention Description
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
Intervention Name(s)
sham EA preconditioning
Intervention Description
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
Primary Outcome Measure Information:
Title
The change of myocardial ischemic injury markers,including serum level of c-reactive protein and Troponin I
Description
to observe the change of the level of multiple myocardial ischemic injury markers at the 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
Secondary Outcome Measure Information:
Title
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
Title
Cardiac ultrasonic scan
Description
be aware of cardiac function
Time Frame
five days pre-operation , five days post-operation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
elective abdominal surgery with coronary heart disease
Exclusion Criteria:
serious bradycardiac arrythmia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shaoyang Chen, M.D.
Organizational Affiliation
Xijing Hospital, the Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing hospital
City
Xi'an
State/Province
Shannxi
ZIP/Postal Code
710032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhaoyang Xiao, Ph.D., M.D.
Phone
86 15009250798
Email
xiaozhaoy2006@hotmail.com
First Name & Middle Initial & Last Name & Degree
Shaoyang Chen, M.D.
12. IPD Sharing Statement
Learn more about this trial
Electroacupuncture Preconditioning on Geriatric Noncardiac Surgery
We'll reach out to this number within 24 hrs