Predictability of ANI (Analgesia Nociception Index) for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- predictive value of ANI monitor for spinal hypotension during cesarean delivery
研究概览
简要总结
Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section. However, the incidence of spinal hypotension is 50-70%, and the decrease in blood pressure is often rapid and severe. Heart rate variability is influenced by various factors such as the sympathetic nervous system, parasympathetic nervous system, temperature regulation, baroreflex, and endocrine regulation, but high frequency heart rate variability above 0.15 Hz very specifically reflects the parasympathetic nervous system. The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system. This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •full-term parturients undergoing cesarean delivery
排除标准
- •emergent surgery, placenta previa, Morbid obesity with a BMI ≥ 40 kg/m2, Gestational age < 36 or ≥ 41 weeks, Contraindications to spinal anesthesia, cardiac arrhythmia, implantable pacemaker, diseases affecting the autoimmune system (such as immune disease or diabetic neuropathy), use of medications affecting ANI monitoring (antimuscarinics, alpha-agonists, beta blockers), illiteracy, or foreigners
结局指标
主要结局
predictive value of ANI monitor for spinal hypotension during cesarean delivery
时间窗: the occurence of hypotension at (within) 1 hour after spinal anesthesia
Investigators will determine the predictive power of the ANI score change for the occurrence of hypotension after spinal anesthesia by drawing a receiver operating characteristic (ROC) curve of the change in ANI score (baseline value - minimum value) and calculating the area under the ROC curve.
次要结局
- Optimal cutoff value of ANI level for predicting occurrence of hypotension(the occurence of hypotension at (within) 1 hour after spinal anesthesia)