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NCT Number: NCT06584097

COMparative Performance of General Purpose Models

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

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Foundation IRCCS Carlo Besta Neurological Institute, Milan, Italy

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About this study

Despite the widespread adoption of Target Controlled Infusion (TCI) models in modern clinical anesthesia practice, much less attention has been paid in the literature to their potential applications in the Intensive Care Unit (ICU) setting. Few studies have been published so far to evaluate the performance of TCI pumps for sedatives and other drugs (e.g., antibiotics) in Intensive Care. Further data is needed regarding the use of TCI for the long-term infusion of these drugs in the ICU after surgery, and the quantitative relationship between generalized pharmacokinetic/pharmacodynamic models for propofol and remifentanil (the Eleveld models) has yet to be evaluated in this specific population. This study is an observational study with the aim of clarifying the predictive performance of the TCI models for the administration of propofol and remifentanil in a cohort of intensive care patients admitted after neurosurgery and compare it to the intraoperative performance, which can be taken as benchmark.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. MdAPE difference for propofol

    Time frame: october 2024

    The difference in MdAPE will be measured when comparing the model performance for propofol in the ICU to the intraoperative phase.

  2. MdAPE difference for remifentanil

    Time frame: october 2024

    The difference in MdAPE will be measured when comparing the model performance for remifentanil in the ICU to the intraoperative phase.

Secondary outcomes

  1. Propofol and remifentanil metabolites

    Time frame: october 2024

    Metabolites of propofol and remifentanil (4-hydroxy propofol and remifentanil acid) during infusion

  2. BIS profile

    Time frame: october 2024

    Bispectral index monitor profile during infusion (min = 0, max = 100)

  3. NOL profile

    Time frame: Oct 2024

    NOL (Nociceptive Level) value (min = 0, max = 100)

  4. RASS

    Time frame: october 2024

    RASS measurements during infusion (min = -5, max = +4).

Study contacts

Contact information is provided by the study sponsor or research team.

Marco Gemma, M.D.

CONTACT

[email protected]

0039022394.2411

Michele Introna, M.D.

CONTACT

[email protected]

00390223942420

Sponsors and collaborators

Lead sponsor

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Other

Collaborators

  • University Medical Center Groningen

Registry information

Official study title

COMparative Performance of General Purpose Models for Propofol And REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 4, 2024
Registry last updated
Feb 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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