Postoperative DeliriumPhase 4NCT07277881
The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal Anesthesia
A Phase 4 study testing remimazolam sedation reversal with flumazenil in people with Postoperative Delirium and Sedation, run by Medical University of Gdansk.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Delirium, Sedation, Remimazolam
- What is being tested?
- remimazolam sedation reversal with flumazenil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Jan 2026to Oct 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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.
Read more
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).
- Conditions
- Postoperative Delirium, Sedation, Remimazolam, Hip Arthroplasty, Total
- Being tested
- remimazolam sedation reversal with flumazenil, placebo
- Medical subject headings
- Emergence Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remimazolam sedation reversal with flumazenilDrug
Immediately after the skin suture is completed, before leaving the operating room, the patient will receive an intravenous bolus administered over 30 seconds containing the contents of a pre-prepared, coded syringe with flumazenil
placeboDrug
Immediately after the skin suture is completed, before leaving the operating room, the patient will receive an intravenous bolus administered over 30 seconds containing the contents of a pre-prepared, coded syringe with placebo (0,9% NaCl)
| Study group | Role | What they receive |
|---|---|---|
| Flumazenil Group | Experimental | Patients will receive a single intravenous bolus of 0.5 mg of flumazenil Receives: Drug: remimazolam sedation reversal with flumazenil |
| Placebo Group | Placebo comparator | Patients will receive a single intravenous bolus of 0.9% NaCl Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Montreal Cognitive Assessment (MoCA) score
The MoCA is a cognitive screening tool. The total score ranges from 0 to 30 points. A higher score indicates better cognitive function.
Measured: from baseline (preoperative) to 24 hours after surgery
Secondary outcomes (13)
Incidence of delirium (defined as a score of ≥ 4 on the 4AT scale)
Measured: within the first 48 hours after surgery, assessed every 6 hours.
Total duration of delirium episodes in hours
Measured: within the first 48 hours after surgery
Preoperative Anxiety Level assessed by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
The Amsterdam Preoperative Anxiety and Information Scale (APAIS) is a questionnaire consisting of 6 items graded on a 5-point Likert scale (ranging from 1 = "not at all" to 5 = "extremely"). The total score ranges from 6 to 30. A higher score indicates higher levels of preoperative anxiety.
Measured: baseline (preoperative)
Montreal Cognitive Assessment (MoCA) score
The MoCA is a cognitive screening tool. The total score ranges from 0 to 30 points. A higher score indicates better cognitive function.
Measured: at 1 and 6 hours after surgery
Mini Montreal Cognitive Assessment (mini-MoCA) scores (telephone assessment)
mini-MoCA is an abbreviated version of the MoCA used for remote assessment. The total score usually ranges from 0 to 15 points. A higher score indicates better cognitive function.
Measured: at 3 and 6 months after surgery
Quality of Recovery-15 (QoR-15) Questionnaire Score
The QoR-15 is a patient-reported outcome measure assessing the quality of recovery after anesthesia and surgery. The total score ranges from 0 to 150. A higher score indicates a better quality of recovery.
Measured: at 24 hours after surgery
The duration of hospital stay
measured in days from the date of surgery to the date of hospital discharge.
Measured: Assessed up to 30 days post-surgery (or through hospital discharge, whichever occurs first).
Maximum and average pain intensity measured by Numeric Rating Scale (NRS) at the following time points
Pain intensity will be assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates "worst pain imaginable".
Measured: 6, 12, 24, and 48 hours after surgery
Total oxycodone consumption (in mg)
Measured: during the first 48 hours after surgery
Mean bispectral index (BIS) during sedation and percentage of time within the optimal range (60-80)
Measured: during surgery
Total dose of remimazolam administered (in mg)
Measured: during surgery
Dose of vasopressor drugs
Measured: during surgery
Need for additional sedative drugs
Measured: during surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative DeliriumStudies of the same condition, open and under way.
- More trials run by Medical University of GdanskThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Gdansk
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cezary Kapłan, Medical University of Gdansk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07277881
- Sponsor's protocol ID
- 429/2025
- Status last verified
- Jan 2026
- First submitted
- 16 Nov 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Reversal of Remimazolam Sedation With Flumazenil on Cognitive Function in Patients Undergoing Hip Arthroplasty Under Spinal Anesthesia
- ClinicalTrials.gov ID
- NCT07277881
- Acronym / sponsor ID
- 429/2025
- Conditions
- Postoperative Delirium, Sedation, Remimazolam, Hip Arthroplasty, Total
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Medical University of GdanskUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Oct 2027 (estimated)
- Study completion
- Oct 2028 (estimated)
- First posted
- 11 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flumazenil Group | Experimental | Drug: remimazolam sedation reversal with flumazenilPatients will receive a single intravenous bolus of 0.5 mg of flumazenil |
| Placebo Group | Placebo comparator | Drug: placeboPatients will receive a single intravenous bolus of 0.9% NaCl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (9 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remimazolam sedation reversal with flumazenilImmediately after the skin suture is completed, before leaving the operating room, the patient will receive an intravenous bolus administered over 30 seconds containing the contents of a pre-prepared, coded syringe with flumazenil | Drug | Flumazenil Group |
| placeboImmediately after the skin suture is completed, before leaving the operating room, the patient will receive an intravenous bolus administered over 30 seconds containing the contents of a pre-prepared, coded syringe with placebo (0,9% NaCl) | Drug | Placebo Group |
Primary outcome
Change in Montreal Cognitive Assessment (MoCA) score
Time frame: from baseline (preoperative) to 24 hours after surgery
The MoCA is a cognitive screening tool. The total score ranges from 0 to 30 points. A higher score indicates better cognitive function.
13 secondary outcomes
Incidence of delirium (defined as a score of ≥ 4 on the 4AT scale)
Time frame: within the first 48 hours after surgery, assessed every 6 hours.
Total duration of delirium episodes in hours
Time frame: within the first 48 hours after surgery
Preoperative Anxiety Level assessed by Amsterdam Preoperative Anxiety and Information Scale (APAIS)
Time frame: baseline (preoperative)
Montreal Cognitive Assessment (MoCA) score
Time frame: at 1 and 6 hours after surgery
Mini Montreal Cognitive Assessment (mini-MoCA) scores (telephone assessment)
Time frame: at 3 and 6 months after surgery
Quality of Recovery-15 (QoR-15) Questionnaire Score
Time frame: at 24 hours after surgery
The duration of hospital stay
Time frame: Assessed up to 30 days post-surgery (or through hospital discharge, whichever occurs first).
Maximum and average pain intensity measured by Numeric Rating Scale (NRS) at the following time points
Time frame: 6, 12, 24, and 48 hours after surgery
Total oxycodone consumption (in mg)
Time frame: during the first 48 hours after surgery
Mean bispectral index (BIS) during sedation and percentage of time within the optimal range (60-80)
Time frame: during surgery
Total dose of remimazolam administered (in mg)
Time frame: during surgery
Dose of vasopressor drugs
Time frame: during surgery
Need for additional sedative drugs
Time frame: during surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing remimazolam sedation reversal with flumazenil in people with Postoperative Delirium and Sedation, run by Medical University of Gdansk.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Montreal Cognitive Assessment (MoCA) score (time frame: from baseline (preoperative) to 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.