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Keep this study
Lead
Vanderbilt University Medical Center
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 the purposes of enrollment and analysis all benzodiazepines used for sedation (mainly midazolam and lorazepam) will be considered equivalent. Patients who are mechanically ventilated and sedated will be enrolled. The initial sedative will be determined by the managing medical team and the medication will be active at the time of enrollment. The patients will then be randomized to either continue their current sedative or be switched to either propofol or dexmedetomidine. PSG data will be collected for up to 96 hours, beginning at enrollment for all patients. The analysis of PSG will not begin until after a 8 hour "washout" period has completed to minimize carryover effect of prior sedatives.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units