Neurosurgical Patients
Conditions
Keywords
Neuroanesthesia, total intravenous anesthesia, target controlled infusion, PKPD modelling
Brief summary
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.
Interventions
None listed
Sponsors
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
University Medical Center Groningen
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Propofol and remifentanil metabolites | october 2024 | Metabolites of propofol and remifentanil (4-hydroxy propofol and remifentanil acid) during infusion |
| BIS profile | october 2024 | Bispectral index monitor profile during infusion (min = 0, max = 100) |
| NOL profile | Oct 2024 | NOL (Nociceptive Level) value (min = 0, max = 100) |
| RASS | october 2024 | RASS measurements during infusion (min = -5, max = +4). |
Countries
Italy
Contacts
CONTACTMichele Introna, M.D.
CONTACTMarco Gemma, M.D.
PRINCIPAL_INVESTIGATORMichele Introna, M.d.
Fondazione IRCCS Istituto Neurologico C. Besta
Outcome results
None listed