Delirium Clinical Trial
— DexOfficial 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.
Status | Completed |
Enrollment | 20 |
Est. completion date | November 2008 |
Est. primary completion date | November 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Austin Health | The Alfred |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time from the commencement of treatment to extubation | the tiem taken to extubate the patient | days | No |
Secondary | Time taken to achieve a satisfactory sedation score (score 3 or 4 on the Riker scale) | time to sedation score | hours | No |
Secondary | The need for supplemental sedative and analgesic medication (morphine, midazolam or propofol, as clinically indicated) | During delivery of trial medication | No | |
Secondary | Average Riker score for agitation | During delivery of trial medication | No | |
Secondary | Average RASS score for agitation | During delivery of trial medication | Yes | |
Secondary | Need for re-intubation | During the same ICU admission | Yes | |
Secondary | Average Bergeron ICDSC score for delirium | During delivery of trial medication | No | |
Secondary | Duration of ICU stay | days | Yes |
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