Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative HRV and Hs-cTnT of Elderly With CHD

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03418194
• Other study ID #: TAESOFLHZ
• Status: Completed
• Phase: N/A
• Start date: February 2, 2018
• Est. completion date: June 30, 2018

Study information

• Verified date: May 2019
• Source: Hebei Medical University Third Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 137
• Est. completion date: June 30, 2018
• Est. primary completion date: June 21, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• transcutaneous acupoint electrical stimulation
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.
• sham transcutaneous acupoint electrical stimulation
Sham transcutaneous acupoint electrical stimulation is the same procedure as transcutaneous acupoint electrical stimulation at points without electronic stimulation.

Locations

Country	Name	City	State
China	Third Hospital of Hebei Medical Universit	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Third Hospital

Country where clinical trial is conducted

China, 

References & Publications (2)

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. Re — View 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, Ackla — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 week
Secondary	heart rate variability	Heart rate variability (HRV) has been verified as a noninvasive indicator of the autonomic nervous system.	1 week
Secondary	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.	1 week
Secondary	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.	1 week