Developing a system for automated control of anaesthesia depth
Official title: Modeling and Closed-loop Control of Depth of Anaesthesia
Run by University of Ljubljana · NCT03569839 · Data updated 2026-11-12
This study is testing a new automated system to better control the depth of anesthesia during surgery to make it safer and more effective for patients.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 20 Years to 70 Years |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | University of Ljubljana Academic / other |
| Locations | 1 site (Ljubljana, Ljubljana) |
| Status | Recruiting |
| Started | September 14, 2017 |
| Main results expected | December 2027 |
| Study ends | December 2028 |
| Registry record updated | May 11, 2026 |
| Trial ID | NCT03569839 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients undergoing vitroretinal or brain surgery requiring general anaesthesia, as well as those needing sedation in the ICU with an ASA classification of 1-3.
✕Probably not a fit
Patients with an ASA classification greater than 3, those with a BMI over 35, or individuals with certain psychiatric or central nervous system conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the effects of anaesthetic agents on the depth of anaesthesia during specific surgical procedures. It aims to develop a closed-loop control system that utilizes a predictive model based on individual patient characteristics and the BIS index to enhance the safety and effectiveness of anaesthesia administration. By simulating various scenarios, the study seeks to improve understanding of pharmacokinetic and pharmacodynamic mechanisms involved in general anaesthesia. The ultimate goal is to create algorithms that can lead to better patient outcomes during surgeries requiring anaesthesia.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective anaesthesia management during surgeries.
How similar studies have gone: While there have been attempts at closed-loop control of anaesthesia, this specific approach is novel and has not yet influenced clinical practice significantly.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients having vitroretinal surgery in general anaesthesia * patients having brain surgery in general anaesthesia * patients needing sedation in ICU * ASA 1-3 Exclusion Criteria: * ASA \> 3 * 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
Where it's running
-
University Medical Centre Ljubljana
Ljubljana, Ljubljana, Slovenia Recruiting
Study contacts
- Principal investigator: Gorazd Karer — University of Ljubljana
- Study coordinator: Gorazd Karer
- Email: gorazd.karer@fe.uni-lj.si
- Phone: +386 1 4768701
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.