跳至主要内容
临床试验/NCT02608775
NCT02608775已完成不适用

Usefulness and Predictive Capacity of ANI and SPI of the Hemodynamic Response to Standardized Stimuli During Neuro- and Urologic Surgery Under Standard Target Controlled Infusion of Propofol and Sufentanil.

Universitair Ziekenhuis Brussel2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
20
试验地点
2
主要终点
The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)

研究概览

简要总结

The primary objective of this study is to investigate the influence of a standardized noxious stimulus on the ANI, SPI and hemodynamic parameters during standard propofol and sufentanil TCI and to see if the ANI and SPI are predictive of a hemodynamic reaction.

In addition the investigators compare the performance of ANI and SPI against one another as well as investigate if ANI or SPI can be used to find the ideal CeSUF for a given patient.

详细描述

During general anesthesia hypnosis can be monitored routinely using EEG derivates like Bispectral index (BIS), entropy,.... However, monitoring analgesia or more precisely the nociceptive-antinociceptive (analgetic) balance during anesthesia proved more difficult. Clinical signs such as heart rate (tachycardia) or blood pressure (hypertension) are usually observed and used to assess nociception and a patient's autonomic unbalance. During general anesthesia administration of opioids like sufentanil and remifentanil decrease the ANS reactivity to noxious stimulation. Recently two variables based on standard anesthesia monitor equipment have been introduced into clinical practice: the Analgesia Nociception Index (ANI), derived from analysis of the small beat-to-beat oscillations of the heart rate during respiration, the heart rate variability (HRV), and the Surgical Pleth Index (SPI), calculated from the plethysmographic amplitude and heart beat interval.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • non-pregnant female participants
  • ASA II-III
  • >18-65 years
  • Weight not exceeding 30% under or above ideal body weight
  • Elective intracranial surgery or circumcision.

排除标准

  • Use concurrent opioid containing drugs
  • Use of any autonomic nervous system altering drugs
  • History of opioid or alcohol abuse
  • Hepatic, renal, metabolic, neuromuscular or cardiovascular disease
  • Known allergies to anesthestetic / analgesic drugs
  • Use of a peripheral nerve block, penile block

结局指标

主要结局

The influence of a standardized noxious stimulus on pain measurement by means of analgesia nociception index (numerical score 0-100)

时间窗: 30 minutes

dimensionless number

次要结局

  • Predictive capacity of ANI and SPI of hemodynamic reactivity by means of analgesia nociception index (numerical score 0-100) or by SPI (numerical index 100-0)(30 minutes)

研究者

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

Veerle Van Mossevelde

Data Nurse

Universitair Ziekenhuis Brussel

研究点 (2)

Loading locations...

相似试验

Usefulness and Predictive Capacity of ANI and SPI of... | 临床试验