an Analgesia-first Strategy Without Hypnotic Sedatives in Adult Patients Admitted to the Intensive Care Unit After Neurosurgical Craniotomy
NCT06727435
Agnosia, Craniotomy
Beijing, China
View Trial DetailsNCT Number: NCT06584097
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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Observational
Foundation IRCCS Carlo Besta Neurological Institute, Milan, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Time frame: october 2024
Metabolites of propofol and remifentanil (4-hydroxy propofol and remifentanil acid) during infusion
Time frame: october 2024
Bispectral index monitor profile during infusion (min = 0, max = 100)
Time frame: Oct 2024
NOL (Nociceptive Level) value (min = 0, max = 100)
Time frame: october 2024
RASS measurements during infusion (min = -5, max = +4).
Contact information is provided by the study sponsor or research team.
Marco Gemma, M.D.
CONTACT
Michele Introna, M.D.
CONTACT
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Other
COMparative Performance of General Purpose Models for Propofol And REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit
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