Pharmacokinetics of Dexmedetomidine During Prolonged Infusion in ICU

Study Overview
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Brief Summary
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The study will examine dexmedetomidine levels in the blood of critically ill intensive care patients to understand how it is broken down by the body.

Official Title
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Pharmacokinetics of Intravenous Dexmedetomidine for Prolonged Infusion in Critically Ill, Ventilated Patients in Intensive Care Unit; an Open, Non-Randomised, Single Centre Study

Conditions
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Pharmacokinetics, Sedation

Intervention / Treatment
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* Drug: Dexmedetomidine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Written informed consent obtained from the patient's legal representative according to local regulations before starting any study procedures other than pre-screening Patients sedated and ventilated in ICU for whom sedation is expected to be clinically required for at least 24 hours, as determined by the responsible physician Prescribed light to moderate sedation (target RASS = 0 to -3) Exclusion Criteria: Acute severe intracranial or spinal neurological disorder due to vascular causes, infection, intracranial expansion or injury Uncompensated acute circulatory failure at screening (severe hypotension with mean arterial pressure(MAP) < 55 mmHg despite vasopressor and inotrope therapy) Heart rate (HR) < 50 beats/min for longer than 5 min between screening and starting study treatment Atrioventricular (AV)-conduction block II-III (unless pacemaker installed) Severe hepatic impairment (e.g. bilirubin > 101 μmol/L) Need for continuous muscle relaxation Any condition which would significantly interfere with the collection of study data Burn injuries or other conditions requiring regular anesthesia or surgery Use of centrally acting alpha-2 agonists or antagonists within 24 hours prior to starting the study (e.g. dexmedetomidine, clonidine, tizanidine, apraclonidine and brimonidine) Known allergy to dexmedetomidine or any excipients of the study treatment Patients who have or are expected to have treatment withdrawn or withheld due to poor prognosis Patients receiving sedation for therapeutic indications rather than to tolerate the ventilator (e.g. epilepsy) Patients unlikely to require continuous sedation during mechanical ventilation (e.g. Guillain-Barré syndrome) Patients who are unlikely to be weaned from mechanical ventilation; e.g. diseases/injuries primarily affecting the neuromuscular function of the respiratory apparatus such as clearly irreversible disease requiring prolonged ventilatory support (e.g. high spinal cord injury or advanced amyotrophic lateral sclerosis)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Dexmedetomidine | Drug: Dexmedetomidine<br>* 2 ml ampoule containing 200 micrograms dexmedetomidine for dilution with 48 ml 0/9% sodium chloride injection. Titrated to efficacy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic variables. |  | From start of treatment to 48 hr follow-up. |