RecruitingNCT03569839

Modeling and Closed-loop Control of Depth of Anaesthesia


Sponsor

University of Ljubljana

Enrollment

50 participants

Start Date

Sep 14, 2017

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Min Age: 20 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

Maintaining the correct depth of anesthesia during surgery is critical — too light and the patient may be aware; too deep and recovery is prolonged with increased side effects. This study develops and tests mathematical models and automated control systems that can monitor depth of anesthesia in real time and adjust drug delivery accordingly, without constant manual input from the anesthesiologist. This is done by analyzing brain activity signals (like EEG), heart rate patterns, and other physiological data. The goal is to create a closed-loop system — similar to cruise control in a car — that keeps anesthesia at exactly the right level throughout an operation. Such systems could improve safety, reduce drug use, and free anesthesiologists to focus on other critical aspects of patient care. You may be eligible if: - You are between 20 and 70 years old - You are undergoing vitreoretinal eye surgery or brain surgery under general anesthesia, or need sedation in an ICU - Your overall health status is ASA class 1–3 You may NOT be eligible if: - Your health status is very poor (ASA class 4 or higher) - Your BMI is above 35 - You use illicit drugs or take regular opioid painkillers - You take psychotropic medications - You have severe psychiatric illness or a central nervous system disease - You have atrial fibrillation or another arrhythmia affecting monitoring - You have taken benzodiazepines recently Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPropofol

Patients undergoing surgery, TIVA (total intravenous anaesthesia)


Locations(1)

University Medical Centre Ljubljana

Ljubljana, Ljubljana, Slovenia

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NCT03569839