COMparative Performance of General Purpose Models

Last updated: October 21, 2024
Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

N/A

Clinical Study ID

NCT06584097
COMPARE ICU
  • All Genders

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 Criteria

Inclusion

Inclusion Criteria:

  • Adult patients undergoing elective neurosurgical procedures with an expectedsedation after surgery of > 12 hours • Requirement for an arterial line

Exclusion

Exclusion Criteria:

  • Pregnancy

  • Known sensitivity or allergy to propofol or remifentanil

  • Patient participating in research for which a period of exclusion is currentlyrequired by other study protocol, ethical committee or health authority.

  • Age < 18 years old

  • Patients subjected to infusion of propofol and/or remifentanil not deliveredthrough TCI pumps before the inclusion

  • Patients exposed to other sedatives (benzodiazepines, volatile anesthetics,quetiapine) before the inclusion

Study Design

Total Participants: 42
Study Start date:
October 02, 2024
Estimated Completion Date:
December 31, 2026

Study Description

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.

Connect with a study center

  • Foundation IRCCS Carlo Besta Neurological Institute

    Milan, 20133
    Italy

    Active - Recruiting

  • Fondazione IRCCS Istituto Neurologico C. Besta

    Milano, 20133
    Italy

    Active - Recruiting

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