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NCT Number: NCT07277881

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

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).

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Key information

Conditions

Postoperative Delirium Confusion Delirium Emergence Delirium Hip Arthroplasty, Total Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurocognitive Disorders Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Remimazolam Sedation Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

remimazolam sedation reversal with flumazenil

Drug

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

Placebo

Drug

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)

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Total duration of delirium episodes in hours

    Time frame: within the first 48 hours after surgery

  3. Preoperative Anxiety Level assessed by Amsterdam Preoperative Anxiety and Information Scale (APAIS)

    Time frame: baseline (preoperative)

    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.

  4. Montreal Cognitive Assessment (MoCA) score

    Time frame: at 1 and 6 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.

  5. Mini Montreal Cognitive Assessment (mini-MoCA) scores (telephone assessment)

    Time frame: at 3 and 6 months after surgery

    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.

  6. Quality of Recovery-15 (QoR-15) Questionnaire Score

    Time frame: at 24 hours after surgery

    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.

  7. The duration of hospital stay

    Time frame: Assessed up to 30 days post-surgery (or through hospital discharge, whichever occurs first).

    measured in days from the date of surgery to the date of hospital discharge.

  8. 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

    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".

  9. Total oxycodone consumption (in mg)

    Time frame: during the first 48 hours after surgery

  10. Mean bispectral index (BIS) during sedation and percentage of time within the optimal range (60-80)

    Time frame: during surgery

  11. Total dose of remimazolam administered (in mg)

    Time frame: during surgery

  12. Dose of vasopressor drugs

    Time frame: during surgery

  13. Need for additional sedative drugs

    Time frame: during surgery

Sponsors and collaborators

Lead sponsor

Medical University of Gdansk

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Dec 11, 2025
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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