Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
Overview
- Phase
- Phase 1
- Intervention
- GABA agonist
- Conditions
- Delirium
- Sponsor
- Vanderbilt University Medical Center
- Enrollment
- 6
- Locations
- 1
- Primary Endpoint
- Time spent in standard sleep stages (N1, N2, N3, REM).
- Status
- Terminated
- Last Updated
- 8 years ago
Overview
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, will improve sleep quality by increasing N2 and N3 sleep as well as total sleep time when compared to GABA agonists.
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 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.
Investigators
Wes Ely
Professor
Vanderbilt University Medical Center
Eligibility Criteria
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
Arms & Interventions
GABA agonist
Intervention: GABA agonist
Alpha 2 agonist
Intervention: Dexmedetomidine
Outcomes
Primary Outcomes
Time spent in standard sleep stages (N1, N2, N3, REM).
Time Frame: 4 days
Secondary Outcomes
- Time spent in atypical sleep.(4 days)
- Presence of burst suppression.(4 days)