drugset / Trial / NCT04758936

Clonidine vs. Dexmedetomidine in Agitated Delirium in Intensive Care Patients

NCT04758936

Phase 4 Unknown 50 enrolled Erasme University Hospital
RandomizedParallel-groupOpen-labelTreatment

Summary

Delirium is one of the most common manifestations of cerebral dysfunction in severely ill patients. The international guidelines for the prevention of delirium in intensive care recommend the daily application of environmental, behavioral and pharmacological strategies. In the case of the agitated form of delirium, experts recommend the use of low-dose neuroleptics and α-2 agonists to control psychotic manifestations rather than traditional sedatives (mainly benzodiazepines) that can clearly aggravate delirium. Currently, two pharmacological α-2 agonists, clonidine (Catapressan®, Boehringer Ingelheim) and dexmedetomidine (Dexdor®, Orion Corporation), are marketed and commonly used in intensive care for their sedative, anxiolytic and analgesic properties. To our knowledge, no studies have compared the effects of clonidine and dexmedetomidine in agitated delirium in intensive care patients. Therefore, our goal is to compare the safety of clonidine and dexmedetomidine (in terms of bradycardia and / or hypotension) in addition to standard treatment in the context of agitated delirium in intensive care patients.

Timeline

Start
2021-02-01
Primary completion
2022-02-28
Completion
2023-02-28

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Clonidine Other / unclassified 0.01 ug/kg
Subject Clonidine Other / unclassified 0.03 ug/kg
Subject Dexmedetomidine Other / unclassified 0.4 ug/kg
Subject Dexmedetomidine Other / unclassified 1.4 ug/kg

Indications