The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients
Status:
Unknown status
Trial end date:
2020-12-01
Target enrollment:
Participant gender:
Summary
Rationale: Delirium is highly prevalent in the ICU. GABA-ergic anaesthetics may provoke
delirium. Alpha-2-adrenergic agonists may lead to a reduction of the total amount of
GABA-ergic anaesthetics and reduction of delirium. There are no large studies proving that
this therapy is effective and safe.
Objective: The objective of this study is to compare the effect of clonidine with placebo on
the occurrence and duration of delirium in mechanically ventilated ICU patients.
Study design: Prospective randomised double-blind placebo controlled intervention study in
115 patients.
Study population: All patients >18 years old, intubated mechanically ventilated and sedated
at inclusion.
Intervention: Clonidine infusion of 0,25 mcg/kg/h added to the standard sedation regimen.
Comparison: NaCl 0,9 % infusion as placebo.
Main study parameters/endpoints: The main study parameter is the total number of awake and
delirium-free observation periods the first 7 days after randomisation. An observation period
is a nursing shift of 8 hours.