Efficacy and Safety of Oral Midazolam Used for the Delivery of Care in Elderly Patient With Neurocognitive Disorders and Refusing Care.

Launched by UNIVERSITY HOSPITAL, GRENOBLE · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called oral midazolam to help provide care for elderly patients who have moderate to severe neurocognitive disorders, like dementia, and who often refuse necessary treatments. The goal is to see if midazolam can make it easier for healthcare providers to deliver important care, such as bathing, medication administration, and other essential procedures, to these patients.

To be eligible for this study, participants must be hospitalized in a geriatric unit for at least 21 days and have significant cognitive impairment, as shown by specific tests. They should also have a history of refusing care despite attempts to help them without medication. Participants will need to give their consent, or have it provided by a legal representative if they cannot make decisions for themselves. It’s important to note that this trial is not yet recruiting participants, and there are specific medical conditions that could exclude someone from joining, such as severe respiratory or liver issues. Overall, this trial aims to find a safer and more effective way to support vulnerable elderly patients in receiving the care they need.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patient hospitalized (for a minimum estimated duration of 21 days) in a geriatric department in Medical Care and Rehabilitation, Cognitive-Behavioral Unit, or housed in a Reinforced Housing Unit, in a Long-Term Care Unit, or in a Psycho-Geriatric Unit.
• • Moderate to severe cognitive impairment, defined by a MMSE (Mini Mental State Examination) score \<15. If not feasible at inclusion, MMSE score \<15 less than 1 year old.
• • Patient opposed to care, presenting at least two episodes of opposition to care (meals excluded) for which other non-medication alternatives have failed. These refusals of care are defined by a \"resistance to care\" score ≥3 on the Pittsburgh scale, over the last week. In practice, the resistance to care of patients is noted in the medical record following a weekly multidisciplinary decision.
• 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
• • Person affiliated with social security or beneficiary of such a scheme
• • Informed, written, and signed consent by the patient or their legal representative (for adults under legal protection and unable to express their consent)
• Exclusion Criteria:
• • Patient who has received midazolam treatment in the week before inclusion
• * Patient with contraindications to midazolam:
• • 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
• • Known hypersensitivity to the active substance, benzodiazepines, or any of the excipients
• * Patient being treated concurrently with:
• • CYP3A4 enzyme inhibitors CYP3A4 enzyme inducers
• • Weight \<50 kg and \>100 kg
• • Gastrointestinal pathology that may limit or prevent the absorption of midazolam
• • Identification of anxiety, defined by item E of the NPI (neuropsychiatric inventory) by an evaluation \>2 in frequency and severity according to HAS recommendations.
• • Identification of pain, defined by the Algoplus scale by an evaluation ≥2
• • Identification of ideational disorders, defined by item E of the Cornell scale: E\>0
• • Subject in the exclusion period of another clinical trial
• • Subject deprived of liberty by an administrative or judicial decision.