The Influence of Electrical Acupoint Stimulation at Different Frequencies on Hemodynamics During Anesthesia Induction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 204
- 主要终点
- incidence of hypotension
研究概览
简要总结
From 15 minutes before to 15 minutes after anesthesia, Transcutaneous Electrical Acupoint Stimulation(TEAS) at different frequencies will be applied at Neiguan and Jian Shi. The changes in blood pressure during the anesthesia induction period will be compared among the high-frequency group ,the low-frequency group and the control group to explore the better frequency to reduce the incidence of post-induction hypotension(PIH) in the elderly.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged over 65 yrs old
- •elective abdominal surgery under general anesthesia
- •written infromed consent
排除标准
- •American society of anesthesiologists status over 3
- •New York Heart Association (NYHA) Functional Classification≥Ⅲ
- •severe arrhythmia leading to hemodynamic instability
- •uncontrolled diabetes
- •hypertension patients stratified as very high risk according to cardiovascular risk classification
- •people who have TEAS contraindications such as local acupoint skin injury or infection and implanted cardiac pacemaker
研究组 & 干预措施
High-frequency
The electrical stimulation is provided at a frequency of 100Hz
干预措施: electrical acupoint stimulation (Other)
High-frequency
The electrical stimulation is provided at a frequency of 100Hz
干预措施: electrodes pasted (Other)
High-frequency
The electrical stimulation is provided at a frequency of 100Hz
干预措施: high-frequency electrical stimulation (Other)
Low-frequency
The electrical stimulation is provided at a frequency of 2Hz
干预措施: electrical acupoint stimulation (Other)
No stimulation
Only electrodes are pasted
干预措施: electrodes pasted (Other)
Low-frequency
The electrical stimulation is provided at a frequency of 2Hz
干预措施: electrodes pasted (Other)
Low-frequency
The electrical stimulation is provided at a frequency of 2Hz
干预措施: low-frequency electrical stimulation (Other)
结局指标
主要结局
incidence of hypotension
时间窗: from start of anesthesia induction to 15 minutes after induction
Hypotension is defined as a Mean arterial pressure (MAP) reduction of more than 20% from baseline or a MAP less than 65 mm Hg for at least 30 seconds. The baseline MAP is measured during the 5 minutes before start of intervention
次要结局
- major in-hospital complication incidence within 5 postoperative days(from start of anesthesia to the 5 days after anesthesia)
- The area under the curve representing the change in mean arterial pressure during the induction period relative to the baseline.(from start of induction to 15 minutes after induction)
- The dosage of vasoactive drugs(from start of induction to 15 minutes after induction)
- lowest MAP(from start of induction to 15 minutes after induction)
- standard deviation of R-R intervals (SDRR)(from start of induction to 15 minutes after induction)
- ratio of low-frequency HRV/high-frequency HRV (LF/HF ratio)(from start of induction to 15 minutes after induction)
研究者
Zhihong LU
Professor
Air Force Military Medical University, China