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Brain surgery sedation: do current dosing models work in the ICU?

NCT ID NCT06584097

Knowledge-focused Sponsor: Fondazione I.R.C.C.S. Istituto Neurologico Carlo Besta Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study checks whether computer models that help doctors dose the sedatives propofol and remifentanil during brain surgery also work well when patients are in the intensive care unit afterward. Researchers will compare how accurate the models are in the ICU versus during surgery. The goal is to see if these models can be used to guide sedation after surgery, potentially improving patient comfort and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
propofol and remifentanil
What this could lead to
If successful, this could improve how doctors dose these sedatives in the ICU after brain surgery, making care safer and more personalized.
What could go wrong
This is a small, early-stage study with only 42 participants, so results may not apply to all patients. It measures drug levels, not direct patient outcomes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 42 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Neurosurgical patients

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Fondazione IRCCS Istituto Neurologico C. Besta

    RECRUITING

    Milan, Milano, 20133, Italy

  • Foundation IRCCS Carlo Besta Neurological Institute

    RECRUITING

    Milan, Italy, 20133, Italy

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