Neurosurgical PatientsNCT06584097
COMparative Performance of General Purpose Models
An observational study of Neurosurgical Patients, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 2 sites in Italy.
Trial summary
To compare the performance of the Eleveld models for propofol and remifentanil on neurosurgery patients admitted to intensive care with their intraoperative performance. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Neurosurgical Patients
- How many people
- 42 participants
- Where
- 2 sitesItaly
- Study dates
- 2 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of > 12 hours
Who may be able to join
- Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of > 12 hours • Requirement for an arterial line
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Italy2 sites, 2 recruiting
- Recruiting
Foundation IRCCS Carlo Besta Neurological Institute
Milan, Italy, 20133
- Recruiting
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, Milano, 20133
Michele Introna, M.D., 0223942420, michele.introna@istituto-besta.it
About this study
Official title: 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.
Read the 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.
- Conditions
- Neurosurgical Patients
- Keywords
- Neuroanesthesia, total intravenous anesthesia, target controlled infusion, PKPD modelling
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: october 2024
Secondary outcomes (4)
Propofol and remifentanil metabolites
Metabolites of propofol and remifentanil (4-hydroxy propofol and remifentanil acid) during infusion
Measured: october 2024
BIS profile
Bispectral index monitor profile during infusion (min = 0, max = 100)
Measured: october 2024
NOL profile
NOL (Nociceptive Level) value (min = 0, max = 100)
Measured: Oct 2024
RASS
RASS measurements during infusion (min = -5, max = +4).
Measured: october 2024
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2024
- Study start2 Oct 2024
- Primary completion1 Oct 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurosurgical PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Center Groningen
- Responsible party
- Sponsor
- Investigators
- Michele Introna, M.d., Principal investigator, Fondazione IRCCS Istituto Neurologico C. Besta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06584097
- Sponsor's protocol ID
- COMPARE ICU
- Status last verified
- Feb 2026
- First submitted
- 10 Jul 2024
- Last updated
- 12 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Propofol and remifentanil pharmacokinetic and pharmacodynamic data.
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMparative Performance of General Purpose Models for Propofol And REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT06584097
- Acronym / sponsor ID
- COMPARE ICU
- Conditions
- Neurosurgical Patients
- Keywords
- Neuroanesthesia, total intravenous anesthesia, target controlled infusion, PKPD modelling
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Fondazione I.R.C.C.S. Istituto Neurologico Carlo BestaUniversity, hospital or other
- Collaborators
- University Medical Center Groningen
- Study start
- 2 Oct 2024 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 4 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of > 12 hours
Key inclusion criteria (1 listed)
- Adult patients undergoing elective neurosurgical procedures with an expected sedation after surgery of > 12 hours • Requirement for an arterial line
Key exclusion criteria (6 listed)
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
4 secondary outcomes
Propofol and remifentanil metabolites
Time frame: october 2024
BIS profile
Time frame: october 2024
NOL profile
Time frame: Oct 2024
RASS
Time frame: october 2024
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2026.
- Individual participant dataSharing planned: Yes. Propofol and remifentanil pharmacokinetic and pharmacodynamic data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michele Introna, M.d. principal investigator
Fondazione IRCCS Istituto Neurologico C. Besta
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurosurgical Patients, run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta at 2 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 12 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michele Introna, M.D. (00390223942420, michele.introna@istituto-besta.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MdAPE difference for propofol (time frame: october 2024). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2026.