Not Yet RecruitingPhase 4

The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal Anesthesia

150 participantsStarted 2026-01

Plain-language summary

This clinical trial aims to establish whether reversing remimazolam sedation with flumazenil can prevent postoperative neurocognitive disorders in patients undergoing total hip replacement surgery. The main questions it aims to answer are: * Does administering flumazenil after surgery lead to an improvement in cognitive function (measured by the MoCA scale) at 24 hours post-operation compared to a placebo? * Does this intervention reduce the incidence of postoperative delirium within the first 48 hours? Researchers will compare flumazenil to a placebo (0.9% saline solution) to see if actively reversing sedation leads to better cognitive outcomes and a lower incidence of delirium. Participants will: * Undergo a planned total hip replacement surgery under spinal anesthesia. * Receive sedation with remimazolam during the operation. * At the end of the surgery, receive an intravenous injection of the study drug (flumazenil) or a placebo. * Undergo assessments for cognitive function (using the MoCA scale) and delirium (using the 4AT scale) before and at multiple time points after the surgery. * Complete a questionnaire about their quality of recovery (QoR-15).

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Montreal Cognitive Assessment (MoCA) score

Timeframe: from baseline (preoperative) to 24 hours after surgery

Trial details

NCT IDNCT07277881

SponsorMedical University of Gdansk

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-10

View on ClinicalTrials.gov More Postoperative Delirium trials