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Waking up the brain: new drug may prevent Post-Surgery confusion

NCT ID NCT07277881

Symptom relief Sponsor: Medical University of Gdansk 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests whether giving flumazenil after hip replacement surgery can reverse the effects of the sedative remimazolam and improve thinking. 150 adults will receive either flumazenil or a placebo right after surgery. Researchers will check their memory and confusion levels over the next two days.

What this could mean

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

Active substance
flumazenil
What this could lead to
If it works, this could point toward a simple way to prevent confusion and memory problems after hip replacement surgery.
What could go wrong
This is a small, early-phase trial. The benefit may be small or not appear at all, and flumazenil can cause side effects like anxiety or rapid heart rate.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 150 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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: * Patient qualified for elective, primary, unilateral, total hip replacement. * Patient assessed on the ASA I-III scale. * MoCA score obtained during screening ≥ 23 points (to exclude patients with significant pre-existing cognitive impairment). * Ability to understand information about the study and express informed, written consent to participate. Exclusion Criteria: * Known hypersensitivity or allergy to benzodiazepines, flumazenil, local anesthetics * Contraindications to spinal anesthesia or patient refusal of this anesthesia technique. * Severe liver dysfunction. * History of epilepsy or seizures * Chronic (daily use for \> 2 weeks in the last 3 months) use of benzodiazepines or non-benzodiazepine hypnotics (so-called "Z" drugs: zolpidem, zopiclone, zaleplon). * Alcohol abuse defined as regular consumption of more than: in men: 40 g of pure ethanol at a time; in women: 20 g of pure ethanol at a time, or a history of psychoactive substance dependence. * Planned revision hip arthroplasty or bilateral surgery. * Significant neurological or psychiatric diseases that may affect the assessment of cognitive function. * The need for sedative premedication.

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Conditions

The condition(s) this trial relates to.

Emergence Delirium

As listed by the trial registrant

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

Hip arthroplasty, total Postoperative delirium Remimazolam Sedation

How to take part

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

  1. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  2. 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.

More trials for these conditions

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