NCT03569839 Modeling and Closed-loop Control of Depth of Anaesthesia
| NCT ID | NCT03569839 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ljubljana |
| Condition | The Focus is to Develop a Closed-loop Control System for Anaesthesia in Vitroretinal Surgery, Surgery Due to Expansive Processes in Head, and Long-term Sedation |
| Study Type | OBSERVATIONAL |
| Enrollment | 50 participants |
| Start Date | 2017-09-14 |
| Primary Completion | 2027-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50 participants in total. It began in 2017-09-14 with a primary completion date of 2027-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 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
Contact & Investigator
Gorazd Karer
PRINCIPAL INVESTIGATOR
University of Ljubljana
Frequently Asked Questions
Who can join the NCT03569839 clinical trial?
This trial is open to participants of all sexes, aged 20 Years or older, up to 70 Years, studying The Focus is to Develop a Closed-loop Control System for Anaesthesia in Vitroretinal Surgery, Surgery Due to Expansive Processes in Head, and Long-term Sedation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03569839 currently recruiting?
Yes, NCT03569839 is actively recruiting participants. Contact the research team at gorazd.karer@fe.uni-lj.si for enrollment information.
Where is the NCT03569839 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT03569839 clinical trial?
NCT03569839 is sponsored by University of Ljubljana. The principal investigator is Gorazd Karer at University of Ljubljana. The trial plans to enroll 50 participants.