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

H

Hebei Medical University Third Hospital

Status

Completed

Conditions

Coronary Artery Disease
Anesthesia

Treatments

Procedure: sham transcutaneous acupoint electrical stimulation
Procedure: transcutaneous acupoint electrical stimulation

Study type

Interventional

Funder types

Other

Identifiers

NCT03418194
TAESOFLHZ

Details and patient eligibility

About

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.

Full 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.

Enrollment

137 patients

Sex

All

Ages

65 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

137 participants in 2 patient groups, including a placebo group

TAES group
Experimental group
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,
Treatment:
Procedure: transcutaneous acupoint electrical stimulation
control group
Placebo Comparator group
Description:
Patients in group C received electrode plate atthe points of PC6 (Neiguan) and PC4 (Ximen) without any electrical stimulation.
Treatment:
Procedure: sham transcutaneous acupoint electrical stimulation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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