COMparative Performance of General Purpose Models
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Neurosurgical Patients. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
COMparative Performance of General Purpose Models for Propofol And REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit
Overview
To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance.
Detailed 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.
Primary outcome measures
- MdAPE difference for propofol [Time frame: october 2024]
- MdAPE difference for remifentanil [Time frame: october 2024]
Secondary outcome measures (4)
- Propofol and remifentanil metabolites [Time frame: october 2024]
- BIS profile [Time frame: october 2024]
- NOL profile [Time frame: Oct 2024]
- RASS [Time frame: october 2024]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
Italy · 2 centers
- Foundation IRCCS Carlo Besta Neurological Institute — Milan
- Fondazione IRCCS Istituto Neurologico C. Besta — Milan
Identifiers
NCT: NCT06584097 · COMPARE ICU