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).
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.
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
Parallel
remimazolam sedation reversal with flumazenil
DrugImmediately 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
DrugImmediately 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)
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.
Incidence of delirium (defined as a score of ≥ 4 on the 4AT scale)
Total duration of delirium episodes in hours
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.
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.
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