Population Pharmacokinetics of Dexmedetomidine in ICU Patients (Dex-Pop-PK)

University of Turku

Status and phase: Completed; Phase 3; Phase 2

Conditions: Pharmacokinetics

Treatments: Drug: Dexmedetomidine

Study type: Interventional

Funder types: Other

Identifiers

NCT00714857

Dex-Pop-PK

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

21 participants in 1 patient group

1

Experimental group

Description:

Patients receiving dexmedetomidine sedation

Treatment:

Drug: Dexmedetomidine