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The purpose of this study is to assess the effectiveness of oral midazolam on the delivery of care in elderly patients with moderat to severe neurocognitive disorders and opposing care.
Neurodegenerative disorders may lead to behavioral disturbances that can result in oppositional reactions, making the performance of certain medical treatments complex.
Midazolam is used to reduce anxiety and agitation in elderly patients with moderate to severe neurocognitive disorders. It has the advantages of rapid action, short half-life, and good tolerability. A recent study shows that its use by subcutaneous (SC) injection 'as needed,' off-label, is becoming increasingly common in elderly patients, particularly to facilitate care. However, SC injection may be poorly tolerated by patients, difficult to administer, and may cause a feeling of mistreatment.
The aim of this clinical trial is to evaluate the efficacy and safety of an oral form of midazolam adapted for the elderly on the performance of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | The nurse administers an oral dose of placebo to the patient |
|
| oral midazolam | Experimental | The nurse administers an oral dose of midazolam to the patient |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| oral administration of midazolam or placebo | Drug | If the patient is opposed to a treatment (resistance to care ≥3 on the Pittsburgh scale), the nurse administers an oral dose of midazolam or placebo to the patient according to the random allocation. |
| Measure | Description | Time Frame |
|---|---|---|
| Evolution of resistance to care following oral administration of midazolam | The efficacy will be evaluated by a decrease of at least two points in the resistance to care dimension of the Pittsburgh scale. the care dimension scale has 4 points, 4 is the worst score, 0 is the better. | For each care: change of the care dimension of the Pittsburgh scale from the time of intention of care and 30 to 45 minutes after the study treatment intake. |
| Measure | Description | Time Frame |
|---|---|---|
| effectiveness of oral midazolam in terms of acceptance of care | The acceptance of care is evaluated using the care acceptance scale by Rignell et al. (2007). This scale rangin from 1 to 4. the wrongest score is. | For each care : This scale is measured immédiately after the end of the care. |
| Evolution of agitation and refusal to care following oral administration of midazolam |
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Inclusion Criteria:
The targeted cares:
Essential nursing care (indispensable, mandatory, and prescribed) Bathing and changing made essential by obvious lack of hygiene after evaluation Bedtime installation (e.g., with the SECURIDRAP® device) technical care: blood tests, wound care, dressing changes, insertion of urinary or nasogastric tubes; administration of medication by parenteral route
Exclusion Criteria:
severe Myasthenia Severe respiratory failure requiring continuous oxygen therapy Severe liver failure: PT <50% Severe sleep apnea syndrome not treated with a device Severe renal failure: Cockcroft <20mL/min Severe heart failure in a state of decompensation History of alcoholism or drug addiction
CYP3A4 enzyme inhibitors CYP3A4 enzyme inducers
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Virginie GARNIER, MD | Contact | 0476767575 | +33 | VGarnier@chu-grenoble.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Geriatric department of Grenoble Alpes university hospital | Recruiting | Grenoble | Isere | 38043 | France |
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This is a "n of one design" study
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Blinding will be carried out upstream by the pharmacy that will prepare the treatment kits.
For each nursing treatment, the syringe will contain either midazolam or placebo according to randomization.
Agitation and refusal of care will be evaluated using the global score of the Pittsburgh Agitation Scale. The scale ranging from 0 to 16. the wrongest score is 16 |
| For each care: change from the time of intention of care and 30 to 45 minutes after the study treatment intake. |
| Number and description of Treatment-Related Adverse Events. | Measurement of saturation, respiratory rate, and heart rate, and collection of serious and non-serious adverse events occurring after the administration of midazolam gel. | From enrollment to the end of treatment at 4 months |
| Satisfaction of the caregiving staff. | Satisfaction questionnaire on the caregivers; sense of well-being towards patients. | For each care: immediatly after the care. |
| ID | Term |
|---|---|
| D019965 | Neurocognitive Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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