Developing a system for automated control of anaesthesia depth
Modeling and Closed-loop Control of Depth of Anaesthesia
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 |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 20 Years to 70 Years |
| Sex | All |
| Sponsor | University of Ljubljana Academic / other |
| Locations | 1 site (Ljubljana, Ljubljana) |
| Trial ID | NCT03569839 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective anaesthesia management during surgeries.
How similar studies have performed: While there have been attempts at closed-loop control of anaesthesia, this specific approach is novel and has not yet influenced clinical practice significantly.
Eligibility criteria
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 this trial is running
Ljubljana, Ljubljana
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.