Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative HRV and Hs-cTnT of Elderly With CHD
Primary Purpose
Coronary Artery Disease, Anesthesia
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
transcutaneous acupoint electrical stimulation
sham transcutaneous acupoint electrical stimulation
Sponsored by

About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Anesthesia, General
Eligibility Criteria
Inclusion Criteria:
- Stable angina pectoris
- Slilent myocardial ischemia
- Remote myocardial infarction
Exclusion Criteria:
- Congenital heart disease
- Have a history of cardiac surgery
- Frequent ventricular / atrial premature beats, atrial fibrillation and other serious arrhythmia
- Heart conduction diseases
- Antiarrhythmic drugs used
- Temporary and permanent pacemaker used
- Intraoperative blood loss>800ml
Sites / Locations
- Third Hospital of Hebei Medical Universit
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
TAES group
control group
Arm Description
Patients in group TAES group received transcutaneous acupoint electrical stimulation (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery,
Patients in group C received electrode plate atthe points of PC6 (Neiguan) and PC4 (Ximen) without any electrical stimulation.
Outcomes
Primary Outcome Measures
High-sensitive cardiac troponin T
Cardiac troponin T are components of the contractile apparatus of myocardial cells and are expressed almost exclusively in the heart. High-sensitive cardiac troponin T is cardiac troponin T mesured by high-sensitive method.
Secondary Outcome Measures
heart rate variability
Heart rate variability (HRV) has been verified as a noninvasive indicator of the autonomic nervous system.
CK
CK is an indicator that reflects the amplitude of operation injury in spine surgery. 1, 3 and 5d after surgery, the serum concentration of CK.
CRP
CRP is a non-specific biomarker of inflammation which has been described as a risk factor for cardiovascular disease. 1, 3 and 5d after surgery, the serum concentration of CRP.
Full Information
NCT ID
NCT03418194
First Posted
January 25, 2018
Last Updated
May 9, 2019
Sponsor
Hebei Medical University Third Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03418194
Brief Title
Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative HRV and Hs-cTnT of Elderly With CHD
Official Title
Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative Heart Rate Variability and High-sensitive Cardiac Troponin of Elderly Patients With Coronary Heart Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 2, 2018 (Actual)
Primary Completion Date
June 21, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hebei Medical University Third Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study was to observe the effect of transcutaneous acupoint electrical stimulation (TAES) on postoperative heart rate variability and high-sensitive cardiac troponin T of elderly patients with coronary heart disease.
Detailed Description
General anesthesia can inhibit sympathetic nerve activity and attenuate stress response, but it also inhibits vagus nerve activity. The decrease of vagus nerve activity can cause cardiovascular complications, especially ventricular arrhythmia in patients with coronary heart disease. Some study have shown that electrical stimulation of transcutaneous acupoints can regulate the function of autonomic nervous system and enhance the activity of vagus nerve so as to protect myocardial tissue. But the effect on autonomic nervous function and myocardial injury markers in elderly patients with coronary heart disease was not reported. Heart rate variability (HRV) is a noninvasive and reliable index reflecting cardiac autonomic nervous function. High-sensitive cardiac troponin hs-cTnT is the best myocardial injury marker.
The investigators plan to recruite 150 patients with coronary heart disease of both sexes, aged 65-80 yr, undergoing elective lumbar decompression and fusion internal fixation surgery. They will be randomly divided into 2 groups(n=75 each)using random number table : control group ( group C ) and TAES group (group T). Patients in group T receive TEAS (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery, the optimal intensity will be adjusted to maintain a slight twitching of the midfinger or ring finger (De-Qi response). Patients in group C receive electrode plate at the same acupoints without any electrical stimulation. Heart rate variability will be collected on 1 day before surgery, 1, 3 and 5d after surgery. 3mL of venous blood will be collected before the induction of anesthesia, 1, 3 and 5d after surgery, the serum will be isolated for the measurement of serum concentration of high-sensitive troponin T (hs-cTnT)、CK、CRP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease, Anesthesia
Keywords
Anesthesia, General
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
137 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TAES group
Arm Type
Experimental
Arm Description
Patients in group TAES group received transcutaneous acupoint electrical stimulation (disperse-dense waves, frequency 4/20Hz) at the points of PC6 (Neiguan) and PC4 (Ximen) from 30 min before anesthesia induction to the end of surgery,
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
Patients in group C received electrode plate atthe points of PC6 (Neiguan) and PC4 (Ximen) without any electrical stimulation.
Intervention Type
Procedure
Intervention Name(s)
transcutaneous acupoint electrical stimulation
Intervention Description
Transcutaneous acupoint electrical stimulation(TAES) is a kind of noninvasive therapy similar to acupuncture and moxibustion. Its physiological effect is similar to that of electroacupuncture and hand acupuncture which is a Chinese traditonal therapy using acupuncture.
Intervention Type
Procedure
Intervention Name(s)
sham transcutaneous acupoint electrical stimulation
Intervention Description
Sham transcutaneous acupoint electrical stimulation is the same procedure as transcutaneous acupoint electrical stimulation at points without electronic stimulation.
Primary Outcome Measure Information:
Title
High-sensitive cardiac troponin T
Description
Cardiac troponin T are components of the contractile apparatus of myocardial cells and are expressed almost exclusively in the heart. High-sensitive cardiac troponin T is cardiac troponin T mesured by high-sensitive method.
Time Frame
1 week
Secondary Outcome Measure Information:
Title
heart rate variability
Description
Heart rate variability (HRV) has been verified as a noninvasive indicator of the autonomic nervous system.
Time Frame
1 week
Title
CK
Description
CK is an indicator that reflects the amplitude of operation injury in spine surgery. 1, 3 and 5d after surgery, the serum concentration of CK.
Time Frame
1 week
Title
CRP
Description
CRP is a non-specific biomarker of inflammation which has been described as a risk factor for cardiovascular disease. 1, 3 and 5d after surgery, the serum concentration of CRP.
Time Frame
1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stable angina pectoris
Slilent myocardial ischemia
Remote myocardial infarction
Exclusion Criteria:
Congenital heart disease
Have a history of cardiac surgery
Frequent ventricular / atrial premature beats, atrial fibrillation and other serious arrhythmia
Heart conduction diseases
Antiarrhythmic drugs used
Temporary and permanent pacemaker used
Intraoperative blood loss>800ml
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xiuli Wang, MD, PhD
Organizational Affiliation
Third Hospital of Hebei Medical Universit Department of Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Huizhou li, M.D
Organizational Affiliation
Third Hospital of Hebei Medical Universit Department of Anesthesiology
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Chuan Wu, M.D
Organizational Affiliation
Third Hospital of Hebei Medical Universit Department of Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Third Hospital of Hebei Medical Universit
City
Shijiazhuang
State/Province
Hebei
ZIP/Postal Code
050051
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
21658013
Citation
Mazzeo AT, La Monaca E, Di Leo R, Vita G, Santamaria LB. Heart rate variability: a diagnostic and prognostic tool in anesthesia and intensive care. Acta Anaesthesiol Scand. 2011 Aug;55(7):797-811. doi: 10.1111/j.1399-6576.2011.02466.x. Epub 2011 Jun 9.
Results Reference
result
PubMed Identifier
28444280
Citation
Writing Committee for the VISION Study Investigators; Devereaux PJ, Biccard BM, Sigamani A, Xavier D, Chan MTV, Srinathan SK, Walsh M, Abraham V, Pearse R, Wang CY, Sessler DI, Kurz A, Szczeklik W, Berwanger O, Villar JC, Malaga G, Garg AX, Chow CK, Ackland G, Patel A, Borges FK, Belley-Cote EP, Duceppe E, Spence J, Tandon V, Williams C, Sapsford RJ, Polanczyk CA, Tiboni M, Alonso-Coello P, Faruqui A, Heels-Ansdell D, Lamy A, Whitlock R, LeManach Y, Roshanov PS, McGillion M, Kavsak P, McQueen MJ, Thabane L, Rodseth RN, Buse GAL, Bhandari M, Garutti I, Jacka MJ, Schunemann HJ, Cortes OL, Coriat P, Dvirnik N, Botto F, Pettit S, Jaffe AS, Guyatt GH. Association of Postoperative High-Sensitivity Troponin Levels With Myocardial Injury and 30-Day Mortality Among Patients Undergoing Noncardiac Surgery. JAMA. 2017 Apr 25;317(16):1642-1651. doi: 10.1001/jama.2017.4360.
Results Reference
result
Learn more about this trial
Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative HRV and Hs-cTnT of Elderly With CHD
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