Conscious Sedation
Conditions
Brief summary
The study aims to demonstrate that dexmedetomidine is non-inferior to current best practice sedation with propofol/midazolam and daily sedation stops, in maintaining a target depth of sedation in long-stay intensive care unit (ICU) patients, and that dexmedetomidine, compared with current best practice, reduces the length of ICU stay.
Interventions
DRUGDexmedetomidine
Sponsors
Orion Corporation, Orion Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Clinical need for sedation and mechanical ventilation * Receiving full intensive care life support * Expected stay in ICU of at least 48 hours (h) from time of admission * Expected requirement for sedation of at least 24h from time of randomisation * Written informed consent within 36h of ICU admission
Exclusion criteria
* Acute severe neurological disorder * Acute uncompensated circulatory failure at time of randomisation * Severe bradycardia * Atrioventricular (AV) conduction block (II-III) unless pacemaker fitted * Severe hepatic impairment * Need for muscle relaxation at time of randomisation * Loss of hearing or vision or any condition interfering significantly with RASS assessment * Positive pregnancy test or currently lactating
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of time during sedative infusion with a Richmond Agitation Sedation Scale (RASS) score within the individually-prescribed target range | — |
| Time from ICU admission to discharge | — |
Secondary
| Measure | Time frame |
|---|---|
| Length of total hospital stay | — |
| Functional recovery during hospitalisation | — |
| Need for rescue medication to maintain sedation | — |
| Frequency of delirium | — |
| Frequency of organ failures and failure-free days | — |
| Nurse's assessment of subject communication | — |
| ICU- and in-hospital survival | — |
| Cost of care in the ICU | — |
| Total cost of hospitalisation | — |
| Blood levels of dexmedetomidine seen with long-term treatment | — |
| Frequency of critical illness polyneuropathy | — |
| Duration of mechanical ventilation, weaning time and ventilator-free days in ICU | — |
Countries
Finland, Switzerland
Outcome results
None listed