None listed
Conditions
Brief summary
This is a pilot feasibility randomized clinical trial comparing the novel intramuscular use of dexmedetomidine, an alpha-2 agonist agent, in preventing delirium and improving sleep in older, non-ventilated intensive care patients, compared with usual care. The main aims are to determine if using the drug in this context is safe, and if further, larger studies would be feasible.
Interventions
• A daily dose of 1 mcg/kg dexmedetomidine (max of 100 mcg).
• Given intramuscularly in the deltoid or gluteal muscle between 7 – 9 pm
• Administered while in the ICU for up to a maximum of five days
Sponsors
Monash Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients must satisfy ALL of the following inclusion criteria: 1. Aged 65 or older on the day of screening. 2. Expected to stay in ICU for longer than 24 hours. 3. Not receiving invasive mechanical ventilation 4. Arterial line in situ prior to the first dose of the drug to enable blood sampling
Exclusion criteria
Exclusion Criteria Patients must not have ANY of the following exclusion criteria: 1. Any contraindication or allergy to dexmedetomidine 2. Patients admitted with any form of acute neurological disturbance a. Suspected or proven acute primary brain injury b. Acute encephalopathy or altered level of consciousness c. Patients receiving therapy for delirium or agitation d. Documented history of cognitive decline or dementia e. Chronically receiving multiple antipsychotic medications 3. Haemodynamic Concerns, defined as: a. Requiring significant vasopressor support i. Norepinephrine > 0.2 mcg/kg/min or equivalent b. Heart rate <50/min in the absence of a functioning pacemaker c. Systolic blood pressure of < 100 mmHg with or without pressor support 4. Significant coagulopathy defined by either of: a. Platelets of < 50,000 b. INR > 3 5. Acute fulminant hepatic failure 6. Pregnancy or active breastfeeding 7. Incipient mortality, or moribund patient likely to die within the next 48h 8. Undergoing active palliative care intervention at the end of life 9. Unable to receive intramuscular injections for any reason 10. Enrolled in other trials of dexmedetomidine 11. Previously enrolled in this study 12. Any other relevant significant clinical reason identified by the treating team
Outcome results
None listed