Status:
TERMINATED
How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units
Lead Sponsor:
Vanderbilt University Medical Center
Conditions:
Delirium
Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to study the effect of two standard of care sedative medications on sleep stages and total sleep time. The investigators hypothesize that the α2 agonist, dexmedetomidine, ...
Detailed Description
This is a single center randomized pilot study comparing the effects of an α2 agonist (dexmedetomidine) versus GABA agonists (propofol or a benzodiazepine) on total sleep time and sleep quality. For t...
Eligibility Criteria
Inclusion
- Adult patients admitted to the medical intensive care unit who require mechanical ventilation and are sedated with a GABA agonist with the expectation of being mechanically ventilated for greater than 24 hours.
Exclusion
- Subjects who are less than 18 years
- Subjects who are pregnant (a pregnancy test will be performed on all women of child bearing age)
- Inability to obtain informed consent from the patient or his/her surrogate
- Subjects who are physiologically benzodiazepine dependent, and at risk of withdrawal syndromes
- Subjects with anoxic brain injuries, strokes, or neurotrauma
- Medical team following patient unwilling to change sedation regimen
- Subjects who are moribund and not expected to survive 24 hours or actively withdrawing medical support
- Documented allergy to study medications
- Subjects with advanced heart block at time of screening
- Prisoners
- RASS target of less than or equal to -4 at the time of screening
- PSG equipment unavailable
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00826553
Start Date
January 1 2009
End Date
December 1 2013
Last Update
June 5 2017
Active Locations (1)
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1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232