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

Обзор

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).

Вмешательства

• Препарат remimazolam sedation reversal with flumazenil
  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
• Препарат placebo
  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)

Первичные конечные точки

• Change in Montreal Cognitive Assessment (MoCA) score [Срок оценки: from baseline (preoperative) to 24 hours after surgery]

Вторичные конечные точки (12)

• Incidence of delirium (defined as a score of ≥ 4 on the 4AT scale) [Срок оценки: within the first 48 hours after surgery, assessed every 6 hours.]
• Total duration of delirium episodes in hours [Срок оценки: within the first 48 hours after surgery]
• Preoperative Anxiety Level assessed by Amsterdam Preoperative Anxiety and Information Scale (APAIS) [Срок оценки: baseline (preoperative)]
• Montreal Cognitive Assessment (MoCA) score [Срок оценки: at 1 and 6 hours after surgery]
• Mini Montreal Cognitive Assessment (mini-MoCA) scores (telephone assessment) [Срок оценки: at 3 and 6 months after surgery]
• Quality of Recovery-15 (QoR-15) Questionnaire Score [Срок оценки: at 24 hours after surgery]
• The duration of hospital stay [Срок оценки: 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 [Срок оценки: 6, 12, 24, and 48 hours after surgery]
• Total oxycodone consumption (in mg) [Срок оценки: during the first 48 hours after surgery]
• Mean bispectral index (BIS) during sedation and percentage of time within the optimal range (60-80) [Срок оценки: during surgery]
• Total dose of remimazolam administered (in mg) [Срок оценки: during surgery]
• Dose of vasopressor drugs [Срок оценки: during surgery]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Тройное слепое

Основная цель

Профилактика

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07277881 · 429/2025

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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