Electrical Acupoint Stimulation Alleviates Hypotension After Spinal Anesthesia in Parturients: a Prospective Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- incidence of hypotension by 30 minutes after spinal anesthesia
研究概览
简要总结
The parturients may suffer from hypotension after spinal anesthesia and the incidence could be as high as 70-80% when pharmacological prophylaxis is not used. Acupuncture was reported to treat hypotension both in human and animal studies. Possible mechanisms include modulating cardiovascular and sympathetic system. In this prospective, double-blinded, randomized clinical trial, we tend to investigate the effect of transcutaneous electric acupoint stimulation (TEAS) on hypotension in parturients undergoing cesarean section.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age ≥18 years
- •American Society of Anesthesiologists physical status Ⅰ-Ⅱ
- •singleton pregnancy
- •full-term gestation (≥38 weeks)
排除标准
- •Parturients suffering from preeclampsia
- •Parturients with hypertension, diabetes, or cardiac dysfunction
研究组 & 干预措施
control
干预措施: electrodes attached (Other)
low frequency stimulation
干预措施: low frequency acupoint stimulation (Other)
low frequency stimulation
干预措施: electrodes attached (Other)
high frequency stimulation
干预措施: high frequency acupoint stimulation (Other)
high frequency stimulation
干预措施: electrodes attached (Other)
结局指标
主要结局
incidence of hypotension by 30 minutes after spinal anesthesia
时间窗: from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes
Hypotension episodes, defined as reductions in systolic blood pressure exceeding 30% of baseline or \<90 mm Hg
次要结局
- dose of atropine(from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes)
- incidence of apnea(from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes)
- dose of ephedrine(from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes)
- lowest systolic blood pressure during 30 minutes after spinal anesthesia(from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes)
- nausea and vomiting score(from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes)
- incidence of dizzy(from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes)
- incidence of chest congestion(from injection of anesthetics to 30 minutes after injection, in a total of 30 minutes)
- Apgar score at 1 minute(1minute after birth)
研究者
Zhihong LU
Associate professor
Air Force Military Medical University, China