Clinical trial NCT00826553: How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units
Official title: Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Delirium
Respiratory Failure
Keywords: sedative
GABA
alpha 2 agonist
propofol
midazolam
lorazepam
dexmedetomidine
sleep
electroencephalogram
polysomnogram
ICU
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2009-01-22
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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
* RASS target of less than or equal to -4 at the time of screening
* PSG equipment unavailable

Primary outcomes:
measure: Time spent in standard sleep stages (N1, N2, N3, REM).
timeFrame: 4 days
Secondary outcomes:
measure: Time spent in atypical sleep.
timeFrame: 4 days
measure: Presence of burst suppression.
timeFrame: 4 days
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt School of Medicine
name: Paula L Watson, MD
role: PRINCIPAL_INVESTIGATOR
References: