COMparative Performance of General Purpose Models

February 10, 2026 updated by: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Italy
    • Italy
      • Milan, Italy, Italy, 20133
        • Recruiting
        • Foundation IRCCS Carlo Besta Neurological Institute
    • Milano
      • Milan, Milano, Italy, 20133

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
MdAPE difference for propofol
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.
october 2024
MdAPE difference for remifentanil
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.
october 2024

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Propofol and remifentanil metabolites
Time Frame: october 2024
Metabolites of propofol and remifentanil (4-hydroxy propofol and remifentanil acid) during infusion
october 2024
BIS profile
Time Frame: october 2024
Bispectral index monitor profile during infusion (min = 0, max = 100)
october 2024
NOL profile
Time Frame: Oct 2024
NOL (Nociceptive Level) value (min = 0, max = 100)
Oct 2024
RASS
Time Frame: october 2024
RASS measurements during infusion (min = -5, max = +4).
october 2024

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University Medical Center Groningen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michele Introna, M.d., Fondazione IRCCS Istituto Neurologico C. Besta

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 2, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 4, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 12, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 10, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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