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临床试验/NCT02766894
NCT02766894已完成不适用

Adequate Depth of Anesthesia: the Anesthesiologist's Assessment and the EEG Processed Monitoring

Kepler University Hospital0 个研究点目标入组 600 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
600
主要终点
Comparison of subjective (anesthesiologist) vs. objective (Narcotrend) assessment of anesthesia depth.

研究概览

简要总结

Comparison of conventional assessment of anesthetic depth by anesthesiologists (moderate, deep or light anesthesia) with EEG monitoring (Narcotrend® state/index). In case of mismatch statistical analysis for underlying factors are done.

详细描述

In this observational study estimation of anesthetic depth by anesthesiologists is compared with the EEG based monitoring Narcotrend®. 10-20 voluntary anesthesiologists of the Kepler University Hospital, unfamiliar with EEG-monitoring during anesthesia, assess depth of anesthesia (moderate, deep or light level) during a steady-state period by clinical signs and measured or calculated concentrations of anesthetics. Concurrently Narcotrend® provides data of anesthetic depth (index, stadium) blinded for the anesthesiologist. Each anesthesiologist is included 30 times during study period. The aim of this study is to define conformity between subjective and objective assessment of narcotic depth. In the cases of divergence data of the patient (age, body mass index, comorbidity...), data of the anesthesiologist (age, years of practice...), data of anesthesia (balanced anesthesia, target controlled infusion, endtidal concentration of volatile anesthetic...) and data of the operation (eye surgery, cardiac surgery...) will be analyzed by statistics with regard to underlying or concomitant factors. These findings could help to develop recommendations in the use of EEG-processed monitoring to improve subjective assessment and facilitate an adequate depth of anesthesia to be provided for every patient.

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
1 Year 至 110 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • operation under general anesthesia
  • duration of surgery ≥ 10 minutes
  • informed consent
  • ASA physical status 1-4
  • age 1-110y
  • performance check of Narcotrend

排除标准

  • proximity of EEG electrodes to the operating field
  • frontal skin lesion
  • frontal cerebral pathology
  • hypoxic brain damage
  • hypothermia (≤33°C)
  • language barrier

结局指标

主要结局

Comparison of subjective (anesthesiologist) vs. objective (Narcotrend) assessment of anesthesia depth.

时间窗: up to 1 year

Depth of anesthesia will be assessed by the anesthesiologist in an subjective way. During a defined period of stable anesthesia state, the indicated subjective depth levels will be assessed by the anesthesiologist and will be compared to those obtained by narcotrend (Narcotrend-Index). Anesthesiologists will assess by deep, moderate and superficial depth of anesthesia. Narcotrend indices will also be assigned to three groups (superficial, moderate, deep levels). After the procedure, both systems will be compared. In the case of non-correlation, other factors like i.e. patient's age, comorbidities, years of practice of the anesthesiologist etc. will be analysed for any other type of correlation.

次要结局

未报告次要终点

研究者

发起方
Kepler University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Wolfgang Puchner MD

MD

Kepler University Hospital

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