How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units
Information source: Vanderbilt University
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sedative Effects; Respiratory Failure
Intervention: Dexmedetomidine (Drug); GABA agonist (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Vanderbilt University Overall contact:
Matthew S King, MD, Phone: (615) 936-5967, Email: matthew.king@vanderbilt.edu
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.
Clinical Details
Official title: Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
Study design: Other, Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment
Primary outcome: Time spent in standard sleep stages (N1, N2, N3, REM).
Secondary outcome: Time spent in atypical sleep.Presence of burst suppression.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Matthew S King, MD, Phone: (615) 936-5967, Email: matthew.king@vanderbilt.edu
Vanderbilt Medical Center, Nashville, Tennessee 37232, United States
Additional Information
Starting date: January 2009
Ending date: June 2010
Last updated: January 21, 2009
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