Clinical trial NCT06584097: COMparative Performance of General Purpose Models
Official title: COMparative Performance of General Purpose Models for Propofol and REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neurosurgical Patients
Keywords: Neuroanesthesia
total intravenous anesthesia
target controlled infusion
PKPD modelling
Lead sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
Sponsor class: OTHER
Collaborators: name: University Medical Center Groningen
First posted: 2024-09-04
Enrollment: 42
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of \> 12 hours

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.

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

Primary outcomes:
measure: MdAPE difference for propofol
timeFrame: october 2024
measure: MdAPE difference for remifentanil
timeFrame: october 2024
Secondary outcomes:
measure: Propofol and remifentanil metabolites
timeFrame: october 2024
measure: BIS profile
timeFrame: october 2024
measure: NOL profile
timeFrame: Oct 2024
measure: RASS
timeFrame: october 2024
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Fondazione IRCCS Istituto Neurologico C. Besta
city: Milan
country: Italy
facility: Foundation IRCCS Carlo Besta Neurological Institute
Study officials:
affiliation: Fondazione IRCCS Istituto Neurologico C. Besta
name: Michele Introna, M.d.
role: PRINCIPAL_INVESTIGATOR
References: