COMparative Performance of General Purpose Models

Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Status: Enrolling

Conditions: Neurosurgical Patients

Study type: Observational

Funder types: Other

Identifiers

NCT06584097

COMPARE ICU

Details and patient eligibility

About

To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance.

Full 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.

Enrollment: 42 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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