COMparative Performance of General Purpose Models | NCT06584097

Studies
COMparative Performance of General Purpose Models

NCT06584097

Sponsor

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

Status

Recruiting

Last Update Posted

Feb 12, 2026Actual

Enrollment

42Estimated

Phase

Not provided

Conditions

Neurosurgical Patients

Interventions

Not provided

Countries

Italy

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2, 2024Actual

Primary Completion Date

Oct 1, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jul 10, 2024

First Submission Date that Met QC Criteria

Sep 2, 2024

First Posted Date

Sep 4, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2026

Last Update Posted Date

Feb 12, 2026Actual

Name	Class
University Medical Center Groningen	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

42Estimated

Outcomes Module

Primary Outcomes

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 Outcomes

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)

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Michele Introna, M.D.	Contact	00390223942420		michele.introna@istituto-besta.it
Marco Gemma, M.D.	Contact	0039022394.2411		marco.gemma@istituto-besta.it

Overall Officials

Name	Affiliation	Role
Michele Introna, M.d.	Fondazione IRCCS Istituto Neurologico C. Besta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Foundation IRCCS Carlo Besta Neurological Institute	Recruiting	Milan	Italy	20133	Italy

IPD Sharing Statement Module

Plan to Share IPD

Yes

Description

Propofol and remifentanil pharmacokinetic and pharmacodynamic data.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided