Comparing anesthesia models for neurosurgery patients in intensive care
Official title: COMparative Performance of General Purpose Models for Propofol And REmifentanil in Neurosurgical Patients Admitted to the Intensive Care Unit
Run by Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta · NCT06584097 · Data updated 2026-11-12
This study is testing how well certain anesthesia models work for patients recovering from brain surgery in the ICU to see if they help manage sedation better than during the surgery itself.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 42 (estimated) |
| Sponsor | Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Academic / other |
| Locations | 2 sites (Milan, Italy and 1 other locations) |
| Status | Recruiting |
| Started | October 2, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | November 5, 2026 |
| Trial ID | NCT06584097 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adult patients undergoing elective neurosurgical procedures requiring sedation for more than 12 hours post-surgery.
✕Probably not a fit
Patients who are pregnant, allergic to propofol or remifentanil, or those under 18 years old will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to evaluate the performance of the Eleveld pharmacokinetic/pharmacodynamic models for propofol and remifentanil in neurosurgical patients admitted to the intensive care unit. It focuses on the predictive accuracy of Target Controlled Infusion (TCI) models for these sedatives during long-term infusion after surgery, comparing their effectiveness to intraoperative performance. The study seeks to fill a gap in the literature regarding the application of TCI in the ICU setting, where limited data currently exists. By analyzing a cohort of patients, the study will provide insights into the optimal use of these models in critical care.
Why it matters
Potential benefit: If successful, this study could enhance sedation management in neurosurgical patients, leading to improved outcomes in the intensive care setting.
How similar studies have gone: While there is limited literature on TCI models in the ICU, this study aims to provide new insights, indicating a novel approach in this specific context.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Foundation IRCCS Carlo Besta Neurological Institute
Milan, Italy, Italy Recruiting -
Fondazione IRCCS Istituto Neurologico C. Besta
Milan, Milano, Italy Recruiting
Study contacts
- Principal investigator: Michele Introna, M.d. — Fondazione IRCCS Istituto Neurologico C. Besta
- Study coordinator: Michele Introna, M.D.
- Email: michele.introna@istituto-besta.it
- Phone: 00390223942420
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.