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Brain wave monitor may reduce sedative use in heart surgery ICU patients

NCT ID NCT07350122

Symptom relief Sponsor: Medical University of Graz Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Aug 19, 2026 · Updated 3 times

Summary

This study tests whether using a special brain monitor (BIS) to guide sedation can reduce the amount of sedative drugs given to adults in the ICU after heart surgery. About 144 participants will be randomly assigned to either BIS-guided sedation or standard care. The goal is to see if this approach leads to faster recovery and fewer complications like pneumonia or delirium.

What this could mean

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

Active substance
Bispectral Index (BIS) monitor
What this could lead to
If it works, this could lead to safer sedation practices for heart surgery patients in the ICU, potentially reducing time on a ventilator and complications like pneumonia or delirium.
What could go wrong
This is a small, early-stage trial with only 144 participants, so results may not apply to all patients. The benefit of BIS monitoring over standard care is unproven, and there is a risk of no significant improvement.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 144 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2027

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.

Ages

18 years and older

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: * Age ≥ 18 years * Undergoing cardiac surgery with subsequent admission to the intensive care unit (e.g., valve surgery, coronary artery bypass grafting, aortic surgery) * Planned or expected duration of invasive mechanical ventilation \> 6 hours postoperatively * Requirement for continuous sedation during ICU stay Exclusion Criteria: * Pre-existing neurological disorders affecting consciousness or sedation assessment (e.g., severe dementia, epileptic encephalopathy). * Acute neurological events in the perioperative period (e.g., stroke, intracranial hemorrhage). * Severe hepatic dysfunction (Child-Pugh Class C). * Participation in another interventional study potentially affecting sedation or cognitive outcomes. * Pregnancy or lactation. * Do-not-intubate (DNI)/Do-not-resuscitate (DNR) orders or documented limitation of therapy. * Patients in whom short-term survival is deemed unlikely due to the clinical course.

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Conditions

The condition(s) this trial relates to.

Critical Illness delirium Emergence Delirium Pneumonia, Ventilator-Associated Postoperative Complications

As listed by the trial registrant

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

Cardiac surgical procedures (postoperative population) Critical illness Delirium, postoperative Pneumonia, ventilator-associated Postoperative complications (cardiopulmonary)

How to take part

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

  1. 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 ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.