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临床试验/NCT03569839
NCT03569839招募中不适用

Modeling and Closed-loop Control of Depth of Anaesthesia

University of Ljubljana2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2017年9月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
50
试验地点
2
主要终点
Depth of anaesthesia

研究概览

简要总结

The study evaluates the effect of anaesthetic agents to depth of anaesthesia. An improved PK-PD model wil be developed that will provide the basis for understanding the mechanisms, simulating various scenarios and developing algorithms for better and safer administration of anaesthetic agents.

详细描述

Scientific background

An increasing degree of automation and informatisation of dynamical processes enables higher quality of achieved goals, lower costs and lower eventual impact on humans and nature alike. Automatic control is an infrastructural field that comprises mathematical modelling, simulation of dynamical systems and automatic control methods. The systematic approach enables the use of control methods in various technical and nontechnical fields, therefore, the advances in automatic control are very useful in interdisciplinary projects.

Likewise, there are many processes in medicine that can be improved by automatic control. In the literature, there have been some approaches to closed-loop control of depth of anaesthesia, but none seem to have influenced clinical practice. Within the project the investigators will develop a system for closed-loop control of depth of anaesthesia using BIS index, which will be based on a predictive model and will consider individual properties of each patient that are obtained from the measurements.

Problem identification

To perform a general anaesthesia, it is necessary to use substances, which enable deep unconsciousness, analgesia, amnesia and muscle relaxation, all required for performing a surgery or a diagnostic procedure. General anaesthesia and related dynamic activities in the human body is a complicated process, which includes pharmacokinetic and pharmacodynamic mechanisms, which have not been fully studied yet.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients having vitroretinal surgery in general anaesthesia
  • patients having brain surgery in general anaesthesia
  • patients needing sedation in ICU

排除标准

  • BMI > 35
  • drug addicts
  • patients taking psychotropic medicines
  • patients taking opioid analgesics (including tramadol)
  • severe psychiatric disease
  • central nervous system disease (except the reason for surgery)
  • arrhythmia affecting or preventing the measurements (e.g. chronic atrial fibrillation)
  • patients that received benzodiazepines

研究组 & 干预措施

Patients undergoing surgery

Patients subject to TIVA

干预措施: Propofol (Drug)

结局指标

主要结局

Depth of anaesthesia

时间窗: Duration of operation.

Depth of anaesthesia is primarily assessed by measuring the BIS index and hemodynamic signals.

Inflow of anaesthetic agents and the relevant concentrations

时间窗: Duration of operation.

The inflow of the agents (e.g. propofol, remifentanil) is measured by infusion pumps. The appropriate concentrations (plasmatic and effect-site) are calculated by the relevant PK models and the effect of the agents is assessed using PD models. The concentrations are compared to the measurements.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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