A Comparison of Dexmedetomidine and Haloperidol in Patients With Intensive Care Unit (ICU)-Associated Agitation and Delirium

• Status: Completed
• Trial end date: 2008-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Austin Health
• Collaborator: The Alfred
• Treatments: Dexmedetomidine; Haloperidol; Haloperidol decanoate

Criteria

Inclusion Criteria:

• Patients will be eligible for the study if, in the opinion of the treating clinician, they continue to require mechanical ventilation only because their degree of agitation requires such a high dose of sedative medication (midazolam or propofol, the only commonly used specific sedatives in our unit) that extubation is not possible.

Exclusion Criteria:

• Patients who could not be extubated even if delirium or agitation were corrected. This will include:

• Patients receiving high dose opioid analgesia (>20 m/morphine/day)

• Patients shortly to return to the operating theatre

• Patients undergoing repeated invasive procedures, in whom it is desirable to maintain deep sedation.

• Patients likely to require ongoing airway protection or control, or ventilatory support (for example, spinal patients with an inadequate vital capacity)

• Known allergy to haloperidol or alpha2 agonists