Pharmacokinetics
Conditions
Keywords
ICU patients, Dexmedetomidine, Sedation, Judged, Attending, Physician
Brief summary
Dexmedetomidine is a new, highly selective and potent alpha2-adrenoreceptor agonist registered for sedation of patients in intensive care units. Although the pharmacokinetics of dexmedetomidine have been studied previously also in an ICU setting, there is no information on the pharmacokinetics of long-lasting (\>48 hours) dexmedetomidine infusions in humans. The aim of this study is to study the pharmacokinetics of long-lasting dexmedetomidine infusions in ICU patients using the population pharmacokinetics approach.
Interventions
DRUGDexmedetomidine
The patients are given a normal loading dose (10 min infusion at a rate of 3-6 μg/kg/h) of dexmedetomidine followed by continuous infusion of 0.1 - 2.5 μg/kg/h for the period of time the responsible physician finds reasonable.
Sponsors
University of Turku
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥ 18 years. * Need for dexmedetomidine sedation (determined by the responsible physician). * Predicted length of dexmedetomidine sedation ≥ 48 hours. * Written informed consent from the patient or the relatives of the participating patient.
Exclusion criteria
* A previous history of intolerance to the study drug or related compounds and additives. * Existing significant haematological, endocrine, metabolic or gastrointestinal disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pharmacokinetic parameters | Blood samples are taken three times daily for characterizing the pharmacokinetic parameters |
Countries
Finland
Outcome results
None listed