Based on Non-invasive Cardiac Output Monitoring System to Explore the Preventive and Therapeutic Effect of Transcutaneous Acupoint Electrical Stimulation on Hypotension After Intraspinal Anesthesia in Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- incidence of hypotension
研究概览
简要总结
The purpose of this study is to assess the prevention and treatment effect of transcutaneous acupoint electrical stimulation on hypotension after intraspinal anesthesia.
详细描述
After being informed about the study and potential risks, all patients giving written informed consent will undergo the doctors' and researchers' examination to determine eligibility for study entry. At beginning of the study, patients who meet the eligibility requirements will be randomized in a open manner（participant and electroacupuncture executor）in a 1:1 ratio to TEAS group (10 minutes before intraspinal anesthesia, bilateral Neiguan points and Zusanli points are given dense wave transcutaneous acupoint electrical stimulation with the frequency of 10/50Hz. The intensity is based on the maximum tolerance of the participant, and the stimulation last until 30 minutes after subarachnoid administration) or Control group (Electrodes are connected at bilateral Neiguan points and Zusanli points 10 minutes before intraspinal anesthesia, but no transcutaneous acupoint electrical stimulation is given, the duration is the same as that of the TEAS group).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •18 years ≤ age < 55 years
- •ASA classification I ~ II
- •full term (37 weeks ≤ gestational weeks < 42 weeks)
- •fchedule for elective single cesarean section under spinal anesthesia
- •no other clinical trial 3 months before the enrollment
- •volunteer to participate and sign the informed consent form
排除标准
- •severe preeclampsia or hypertension
- •cardiac insufficiency
- •mental abnormality or cognitive impairment or inability to communicate
- •acupuncture points skin breakage, infection, allergy
- •the researchers believe that there are any conditions that are not suitable for inclusion.
结局指标
主要结局
incidence of hypotension
时间窗: within 30 minutes after subarachnoid administration
the incidence of hypotension within 30 minutes after subarachnoid administration in TEAS group was significantly lower than that in Control group.
次要结局
- incidence of nausea and vomiting(within 30 minutes after subarachnoid administration)
- incidence of dizziness, chest tightness and dyspnea(within 30 minutes after subarachnoid administration)
- specific changes of hemodynamic indexes(within 30 minutes after subarachnoid administration)
- usage of ephedrine(within 30 minutes after subarachnoid administration)