Delirium Clinical Trial
Official title:
A Randomised Open Label Pilot Study of the Efficacy of Dexmedetomidine and Haloperidol in Ventilated Patients With ICU-associated Agitation and Delirium
The purpose of the study is to determine whether dexmedetomidine is a more effective
medication than haloperidol in the treatment of agitation and delirium in patients receiving
mechanical ventilation in an intensive care unit. Haloperidol is a medication conventionally
used for this purpose.
The investigators will study only patients who have recovered from their illness to the
point that, were it not for agitation and delirium, they would no longer require mechanical
ventilation.
The investigators hypothesize that patients receiving dexmedetomidine will be able to
discontinue mechanical ventilation earlier than those receiving haloperidol.
Up to 80% of patients undergoing intensive care have delirium. Early in the ICU stay,
delirium and agitation are usually prevented using analgesic and sedative drugs which
essentially render the patient unconscious. This is appropriate in the context of aggressive
treatment of pathophysiological instability, which often requires multiple painful
procedures. However, after the underlying pathophysiological problem has resolved, patients
sometimes remain delirious and agitated. This often requires ongoing heavy sedation, which
in turn necessitates continued mechanical ventilation, and can worsen the (temporarily
masked) delirium. Prolonged mechanical ventilation increases the risk of ventilator
associated pneumonia and other life threatening complications.
The drug most commonly used to treat delirium is haloperidol, which reduces hallucinations
and unstructured thought patterns, but also reduces the interaction with the environment.
Haloperidol has significant side effects, including extrapyramidal reactions (in 1-10% of
patients), neuroleptic malignant syndrome (in which it is the cause in 50% of cases), and
prolonged QT syndrome (which can precipitate fatal arrhythmias).
An ideal sedative agent in this context would have fewer side effects, relieve agitation
without causing excessive sedation, and be easily titrated. An analgesic action might allow
less opioid use, also lessening delirium. Early studies in other contexts suggest
dexmedetomidine has all these properties.
The investigators hypothesise that patients with ICU-associated delirium after the
resolution of their underlying pathological process who receive dexmedetomidine will be able
to be extubated earlier than those who receive haloperidol.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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