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

NCT00505804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2013-01-24

No results posted yet for this study

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.

Conditions

  • Delirium
  • Agitation
  • Ventilator Weaning
  • Respiration, Artificial
  • Intensive Care

Interventions

DRUG

dexmedetomidine

Dexmedetomidine IV infusion of 0.0 to 0.7 mg/kg/min for as long a deemed necessary by the treating clinician.

DRUG

haloperidol

Haloperidol IV loading dose of 2.5mg, followed by a continuous infusion of 0.0 to 2mg/hr for as long as deemed necessary by the treating clinician

Sponsors & Collaborators

  • The Alfred

    collaborator OTHER

  • Austin Health

    lead OTHER_GOV

Principal Investigators

  • Rinaldo Bellomo, MD FJFICM · Austin Health, University of Melbourne

  • Michael C Reade, MBBS FJFICM · Austin Health, University of Melbourne

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-01-31
Primary Completion
2008-11-30
Completion
2008-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00505804 on ClinicalTrials.gov