Modeling and Closed-loop Control of Depth of Anaesthesia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20-70
SponsorUniversity of Ljubljana
About this trial
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
This trial accepts healthy volunteersQualifiers
patients having vitroretinal surgery in general anaesthesia
patients having brain surgery in general anaesthesia
patients needing sedation in ICU
ASA 1-3
Disqualifiers
ASA > 3
BMI > 35
drug addicts
patients taking psychotropic medicines
Trial population
Patients from the University medical centre Ljubljana planned for vitroretinal surgery, brain surgery or sedation in ICU.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Propofol
DrugPatients undergoing surgery, TIVA (total intravenous anaesthesia)
Treatment groups
50 Participants
are divided into 1 treatment groupGroup A: Patients undergoing surgery1 intervention
Trial outcomes
Primary outcomes
1
Depth of anaesthesia
Depth of anaesthesia is primarily assessed by measuring the BIS index and hemodynamic signals.
Time frame
Duration of operation.2
Inflow of anaesthetic agents and the relevant concentrations
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.
Time frame
Duration of operation.Sponsors and contacts
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Source ClinicalTrials.gov