Status:
COMPLETED
Dexmedetomidine Versus Midazolam for Facilitating Extubation
Lead Sponsor:
University of Colorado, Denver
Collaborating Sponsors:
Hospira, now a wholly owned subsidiary of Pfizer
Conditions:
Critical Illness
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
The purpose of this randomized, double-blind study is to evaluate the utility, safety, and cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical intensive care unit (...
Detailed Description
This study is unique because midazolam or dexmedetomidine will be added, in a blinded fashion, to existing sedation and analgesia in an effort to decrease or possibly discontinue these therapies. Obj...
Eligibility Criteria
Inclusion
- Patients requiring mechanical ventilation in the medical or surgical ICUs.
- Currently receiving lorazepam or midazolam by continuous infusion for the purpose of sedation therapy.
- Sedation in these ICUs is provided using an ICU-wide order form that preferentially uses either lorazepam or midazolam with the infusion rate titrated by the bedside nurse to the desired Riker sedation-agitation score(s). Continuous analgesia is provided with fentanyl only with the infusion rate titrated by the bedside nurse to PABS ≤ 3 .
- Anticipated duration of continuous sedation \> 12 hours with the level of sedation expected to be maintained at Riker sedation-agitation score(s) of 3 - 4.
- Patients qualifying for daily awakenings as determined by all of the following:
- fraction of inspired oxygen (FiO2) ≤ 70% or
- positive end expiratory pressure (PEEP) ≤ 14 cmH2O,
- hemodynamically stable, and
- NOT receiving pharmacologic neuromuscular blockade.
- Informed consent and HIPAA authorization within 24 hours of qualifying for daily awakenings.
Exclusion
- Patients \< 18 years of age or \> 85 years of age.
- Patients receiving intermittent or "as needed" administration of lorazepam or midazolam.
- Patients receiving lorazepam or midazolam for purposes other than sedation (e.g. seizure control).
- Patients receiving epidural administration of medication(s).
- Patients with Childs-Pugh class C liver disease.
- Comatose patients by metabolic or neurologic affectation.
- Patients with active myocardial ischemia or second- or third-degree heart block.
- Moribund state with planned withdrawal of life support.
- Patients with known or suspected severe adverse reactions to midazolam (or any other benzodiazepine) or dexmedetomidine (or clonidine).
- Patients with alcohol abuse within six months of study eligibility.
- Pregnant females or females suspected of being pregnant.
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2012
Estimated Enrollment :
23 Patients enrolled
Trial Details
Trial ID
NCT00744380
Start Date
August 1 2008
End Date
October 1 2012
Last Update
September 28 2016
Active Locations (1)
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1
University of Colorado Hospital
Aurora, Colorado, United States, 80010