How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Hospital, Neurology, Pulmonary |
| Therapuetic Areas: | Neurology, Pulmonary / Respiratory Diseases, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | January 2009 |
| End Date: | December 2016 |
Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
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, will improve sleep quality by increasing N2 and N3 sleep as well
as total sleep time when compared to GABA agonists.
medications on sleep stages and total sleep time. The investigators hypothesize that the α2
agonist, dexmedetomidine, will improve sleep quality by increasing N2 and N3 sleep as well
as total sleep time when compared to GABA agonists.
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.
(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.
Inclusion Criteria:
- 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 Criteria:
- 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
We found this trial at
1
site
1211 Medical Center Dr
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-5000
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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