COMparative Performance of General Purpose Models

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

42 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-02

Study Completion Date

2026-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Neurosurgical Patients

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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

Eligible Sex

ALL

Accepts Healthy Volunteers

No