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Clinical Trials in Italy / NCT06584097
Recruiting Observational

COMparative Performance of General Purpose Models

NCT06584097 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Phase
Observational
Started
2024-10-02
Last updated
2026-02-12

Condition(s) studied

Neurosurgical Patients

Study summary

To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of \> 12 hours • Requirement for an arterial line Exclusion Criteria: * Pregnancy * Known sensitivity or allergy to propofol or remifentanil * Patient participating in research for which a period of exclusion is currently required by other study protocol, ethical committee or health authority. * Age \< 18 years old * Patients subjected to infusion of propofol and/or remifentanil not delivered through TCI pumps before the inclusion * Patients exposed to other sedatives (benzodiazepines, volatile anesthetics, quetiapine) before the inclusion

Primary outcome measure(s)

  • MdAPE difference for propofol — october 2024
    The difference in MdAPE will be measured when comparing the model performance for propofol in the ICU to the intraoperative phase.
  • MdAPE difference for remifentanil — october 2024
    The difference in MdAPE will be measured when comparing the model performance for remifentanil in the ICU to the intraoperative phase.

Trial sites (2)

FacilityCityRegionStatus
Foundation IRCCS Carlo Besta Neurological Institute Milan Italy Recruiting
Fondazione IRCCS Istituto Neurologico C. Besta Milan Milano Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06584097 on ClinicalTrials.gov ↗ ← All trials in Italy