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临床试验/NCT04979039
NCT04979039已完成不适用

Heart Rate Variability Monitoring to Predict Hypotension Following Spinal Anesthesia for Cesarean Delivery: Prospective Observational Study

Seoul National University Bundang Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
50
试验地点
1
主要终点
The change of averaged value

研究概览

简要总结

Based on the patient's heart rate variability, the analgesia nociception index (ANI) measures the activity of the autonomic nervous system and the sympathetic/parasympathetic nervous system and expresses it as a numerical value through a specific algorithm. The investigators will analyze it and see if it has the ability to predict severe hypotension following spinal anesthesia.

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

入选标准

  • Adult pregnant women scheduled for cesarean section under spinal anesthesia

排除标准

  • Emergency cesarean section
  • When performing general anesthesia or epidural anesthesia
  • Multiple pregnancies
  • Surgery in which massive hemorrhage and massive blood transfusion are expected due to placenta previa
  • Cardiac arrhythmias, congestive heart failure, ischemic heart disease, congenital heart anomalies
  • Cranial nervous system disease
  • Autonomic nervous system-related underlying diseases not related to pregnancy
  • Fetal malformations
  • Those who have an allergic skin reaction to adhesive substances such as bandages

结局指标

主要结局

The change of averaged value

时间窗: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room

The change of averaged value presented in ANI monitor

The change of instantaneous value

时间窗: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room

The change of instantaneous value presented in ANI monitor

Total dose of injected phenylephrine

时间窗: During the anesthesia (from initiation of anesthesia until the end of anesthesia)

Total dose of injected glycopyrrolate

时间窗: During the anesthesia (from initiation of anesthesia until the end of anesthesia)

The change of systolic blood pressure

时间窗: Every 1 min after entering the operating room until finishing the operation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hyo-Seok Na

Clinical professor

Seoul National University Bundang Hospital

研究点 (1)

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