Modeling and Closed-loop Control of Depth of Anaesthesia
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
- 是
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
