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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Flumazenil Group | Experimental | Patients will receive a single intravenous bolus of 0.5 mg of flumazenil |
|
| Placebo Group | Placebo Comparator | Patients will receive a single intravenous bolus of 0.9% NaCl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | from baseline (preoperative) to 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of delirium (defined as a score of ≥ 4 on the 4AT scale) | within the first 48 hours after surgery, assessed every 6 hours. | |
| Total duration of delirium episodes in hours | within the first 48 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| 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) |
|
| 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. | 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. | 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. | 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. | at 24 hours after surgery |
| The duration of hospital stay | measured in days from the date of surgery to the date of hospital discharge. | 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". | 6, 12, 24, and 48 hours after surgery |
| Total oxycodone consumption (in mg) | during the first 48 hours after surgery |
| Mean bispectral index (BIS) during sedation and percentage of time within the optimal range (60-80) | during surgery |
| Total dose of remimazolam administered (in mg) | during surgery |
| Dose of vasopressor drugs | during surgery |
| Need for additional sedative drugs | during surgery |
| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D005442 | Flumazenil |
| ID | Term |
|---|---|
| D001570 | Benzodiazepinones |
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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