Population Pharmacokinetics of Dexmedetomidine in ICU Patients (Dex-Pop-PK)
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Population Pharmacokinetics of Dexmedetomidine in ICU Patients|
- Pharmacokinetic parameters [ Time Frame: Blood samples are taken three times daily for characterizing the pharmacokinetic parameters ] [ Designated as safety issue: No ]
|Study Start Date:||October 2007|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Patients receiving dexmedetomidine sedation
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.