Effects of Transcutaneous Acupoint Electrical Stimulation on Postoperative Heart Rate Variability and High-sensitive Cardiac Troponin of Elderly Patients With Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 137
- 试验地点
- 1
- 主要终点
- High-sensitive cardiac troponin T
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 80 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina pectoris
- •Slilent myocardial ischemia
- •Remote myocardial infarction
排除标准
- •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
研究组 & 干预措施
TAES group
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,
干预措施: transcutaneous acupoint electrical stimulation (Procedure)
control group
Patients in group C received electrode plate atthe points of PC6 (Neiguan) and PC4 (Ximen) without any electrical stimulation.
干预措施: sham transcutaneous acupoint electrical stimulation (Procedure)
结局指标
主要结局
High-sensitive cardiac troponin T
时间窗: 1 week
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.
次要结局
- heart rate variability(1 week)
- CRP(1 week)
- CK(1 week)
