跳至主要内容
临床试验/NCT06696781
NCT06696781已完成不适用

NOL Index in Response to Pacemaker Stimulation in Open-heart Surgery

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2024年11月18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
20
试验地点
1
主要终点
NOL index

研究概览

简要总结

The Nociception Level Index (NOL Index) utilizes various signals to assess the balance of nociception and antinociception during anesthesia. Its correlation with nociceptive stimuli and opioids is known, but its response to isolated heart rate changes remains uncertain. The aim is to investigate how cardiac pacing affects the NOL Index.

详细描述

The Nociception Level Index (NOL Index) represents an innovative approach to monitoring nociception during general anesthesia, utilizing a combination of signals from photoplethysmography, accelerometry, thermometry, and skin conductance to assess the balance between nociceptive and antinociceptive states. Research has already established how the NOL Index correlates with both nociceptive stimuli and opioid levels, providing valuable insights into patient responses. However, the impact of changes in heart rate, specifically through isolated cardiac pacing, on the NOL Index is not yet clear. The primary goal of this study is to explore and understand how cardiac pacing might influence the readings of the NOL Index, potentially offering a new dimension to managing anesthesia effectively.

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

入选标准

  • Informed consent
  • Preoperative and postoperative sinus rhythm (50-90 bpm)
  • Norepinephrine support < 100 ng/kg/min

排除标准

  • Redo or emergent surgery
  • History of any cardiac arrhythmia
  • Any cardiocirculatory support other than norepinephrine
  • Perioperative treatment with beta-blockers, calcium-channel blockers or ivabradine

结局指标

主要结局

NOL index

时间窗: Every minute during seven 5-minute intervals under various pacemaker settings, totaling 35 minutes of monitoring.

The Nociception Level Index (NOL Index) quantitatively evaluates the balance between nociception and antinociception in mechanically ventilated postoperative adult patients after elective cardiac surgery, utilizing a multiparametric approach that includes photoplethysmography, accelerometry, thermometry, and skin conductance.

次要结局

未报告次要终点

研究者

发起方
Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu
申办方类型
Other
责任方
Principal Investigator
主要研究者

Balan Ion Cosmin

Principal Investigator

Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu

研究点 (1)

Loading locations...

相似试验

NOL Index in Response to Pacemaker Stimulation | 临床试验