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临床试验/NCT05053633
NCT05053633已完成不适用

Relationship Between Analgesia Nociception Index, Anxiety, and Pain in Conscious Hernia Patients Undergoing Combined Spinal Epidural Anesthesia

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年9月25日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
24
试验地点
1
主要终点
The correlation between ANI and pain (measured with Visual Analog Scale,VAS), ANI and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures

研究概览

简要总结

Analgesia Nociception Index can be used to detect noxious stimulation during general anesthesia.The aim of this study is to observe ANI under combined spinal epidural anesthesia procedures in conscious hernia patients.

详细描述

Analgesia Nociception Index which is derived by heart rate variability, can be used to detect noxious stimulation during general anesthesia. However, the impact of anxiety on ANI evaluation and the correlation between ANI, pain, and anxiety in awake patients remains unclear. This study aimed to investigate the correlation between ANI, pain, and anxiety in conscious hernia patients undergoing combined spinal epidural anesthesia procedures.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 18- 80 years
  • ASA physical status I or II
  • Scheduled for inguinal hernia, umbilical hernia or incisional repair under CSEA
  • Written informed consent

排除标准

  • Use of CNS-active medication or abuse of alcohol
  • History of cardiac arrhythmia
  • Contraindications of combined spinal epidural anesthesia
  • Previous exposure to CSEA or surgery

结局指标

主要结局

The correlation between ANI and pain (measured with Visual Analog Scale,VAS), ANI and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures

时间窗: The changes of ANI, VAS, and VAS-A, from baseline at different Time-points to 2min after anesthesia procedures, (Timepoints: T1=after lateral position, T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture)

ANI is derived from hear rate variability, ranging from 0-100, bigger number means better analgesic level. Patients undergoing CSEA may experience mid-level anxiety while remaining conscious. The anxiety (VAS-A), pain (VAS), and ANI assessments were conducted at four specific time points.

次要结局

  • The correlation between pain (measured with Visual Analog Scale,VAS) and anxiety (measured with Visual Analog Scale-Anxiety,VAS-A) changes in conscious patients during anesthesia procedures(The changes of VAS, and VAS-A, from baseline at different Time-points to 2min after anesthesia procedures, (Timepoints: T2=local anesthesia, T3=epidural needle puncture, and T4=2 minutes after puncture))

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Changwei Wei

Deputy chief physician

Beijing Chao Yang Hospital

研究点 (1)

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