Clinical trial NCT03418194: 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
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Anesthesia
Keywords: Anesthesia, General
Lead sponsor: Hebei Medical University Third Hospital
Sponsor class: OTHER
First posted: 2018-02-01
Enrollment: 137
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: High-sensitive cardiac troponin T
timeFrame: 1 week
Secondary outcomes:
measure: heart rate variability
timeFrame: 1 week
measure: CK
timeFrame: 1 week
measure: CRP
timeFrame: 1 week
Other outcomes:
Locations:
city: Shijiazhuang
country: China
facility: Third Hospital of Hebei Medical Universit
state: Hebei
Study officials:
affiliation: Third Hospital of Hebei Medical Universit Department of Anesthesiology
name: Xiuli Wang, MD, PhD
role: STUDY_CHAIR
affiliation: Third Hospital of Hebei Medical Universit Department of Anesthesiology
name: Huizhou li, M.D
role: STUDY_DIRECTOR
affiliation: Third Hospital of Hebei Medical Universit Department of Anesthesiology
name: Chuan Wu, M.D
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.