The Effect of Clonidine-enhanced Sedation on Delirium in Ventilated Critically Ill Patients

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.

Timeline

Start

2024-01

Primary completion

2024-12

Completion

2025-06

Drugs

Indications