COMparative Performance of General Purpose Models

COMparative Performance of General Purpose Models for Propofol And REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit

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

Study Overview

• Status: Recruiting
• Conditions: Neurosurgical Patients

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.

• Study Type: Observational
• Enrollment (Estimated): 42

Contacts and Locations

• Study Contact: Name: Michele Introna, M.D.; Phone Number: 00390223942420; Email: michele.introna@istituto-besta.it
• Study Contact Backup: Name: Marco Gemma, M.D.; Phone Number: 0039022394.2411; Email: marco.gemma@istituto-besta.it

Study Locations

• Italy
  • Italy
    • Milan, Italy, Italy, 20133
      • Recruiting
      • Foundation IRCCS Carlo Besta Neurological Institute
  • Milano
    • Milan, Milano, Italy, 20133
      • Recruiting
      • Fondazione IRCCS Istituto Neurologico C. Besta
      • Contact: Michele Introna, M.D.; Phone Number: 0223942420; Email: michele.introna@istituto-besta.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of > 12 hours

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MdAPE difference for propofol	The difference in MdAPE will be measured when comparing the model performance for propofol in the ICU to the intraoperative phase.	october 2024
MdAPE difference for remifentanil	The difference in MdAPE will be measured when comparing the model performance for remifentanil in the ICU to the intraoperative phase.	october 2024

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Propofol and remifentanil metabolites	Metabolites of propofol and remifentanil (4-hydroxy propofol and remifentanil acid) during infusion	october 2024
BIS profile	Bispectral index monitor profile during infusion (min = 0, max = 100)	october 2024
NOL profile	NOL (Nociceptive Level) value (min = 0, max = 100)	Oct 2024
RASS	RASS measurements during infusion (min = -5, max = +4).	october 2024

Collaborators and Investigators

• Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
• Collaborators: University Medical Center Groningen
• Investigators: Principal Investigator: Michele Introna, M.d., Fondazione IRCCS Istituto Neurologico C. Besta

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2024
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 10, 2024
• First Submitted That Met QC Criteria: September 2, 2024
• First Posted (Actual): September 4, 2024

Study Record Updates

• Last Update Posted (Actual): February 12, 2026
• Last Update Submitted That Met QC Criteria: February 10, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: total intravenous anesthesia; target controlled infusion; Neuroanesthesia; PKPD modelling
• Other Study ID Numbers: COMPARE ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Propofol and remifentanil pharmacokinetic and pharmacodynamic data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No