Modeling and Closed-loop Control of Depth of Anaesthesia

NCT03569839 | Recruiting FDA Drug

• 1 other identifier: 0120-438/2017
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (2)

• Depth of anaesthesia

  Depth of anaesthesia is primarily assessed by measuring the BIS index and hemodynamic signals.

  Duration of operation.

• 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.

  Duration of operation.

Study Arms (1)

Patients undergoing surgery

Patients subject to TIVA

Drug: Propofol

Interventions

Propofol DRUG

Patients undergoing surgery, TIVA (total intravenous anaesthesia)

Patients undergoing surgery

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients from the University medical centre Ljubljana planned for vitroretinal surgery, brain surgery or sedation in ICU.

You may qualify if:

• patients having vitroretinal surgery in general anaesthesia
• patients having brain surgery in general anaesthesia
• patients needing sedation in ICU
• ASA 1-3

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Ljubljana: lead

Study Sites (1)

University Medical Centre Ljubljana

Ljubljana, Ljubljana, 1000, Slovenia

RECRUITING

MeSH Terms

Interventions

Propofol

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Gorazd Karer

  University of Ljubljana

  PRINCIPAL INVESTIGATOR

• Iztok Potočnik

  University Medical Centre Ljubljana

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gorazd Karer

CONTACT

+386 1 4768701; gorazd.karer@fe.uni-lj.si

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 14, 2018
• First Posted: June 26, 2018
• Study Start: September 14, 2017
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 13, 2025

Record last verified: 2025-04

Locations

SL (1)