How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units - Full Text View

Sponsored by:	Vanderbilt University
Information provided by:	Vanderbilt University
ClinicalTrials.gov Identifier:	NCT00826553

Purpose

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.

Condition	Intervention
Sedative Effects Respiratory Failure	Drug: Dexmedetomidine Drug: GABA agonist

Drug Information available for: Midazolam Midazolam maleate Midazolam hydrochloride Dexmedetomidine Dexmedetomidine hydrochloride Lorazepam Propofol

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Single Blind (Outcomes Assessor), Uncontrolled, Parallel Assignment
Official Title:	Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists

Further study details as provided by Vanderbilt University:

Primary Outcome Measures:

Time spent in standard sleep stages (N1, N2, N3, REM). [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time spent in atypical sleep. [ Time Frame: 4 days ] [ Designated as safety issue: No ]
Presence of burst suppression. [ Time Frame: 4 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	30
Study Start Date:	January 2009
Estimated Study Completion Date:	June 2010
Estimated Primary Completion Date:	June 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
GABA agonist: Experimental	Drug: GABA agonist Patients sedated with GABA agonists (e.g. propofol, benzodiazapenes) during mechanical ventilation will be enrolled. Patients randomized to the GABA agonist arm will continue the sedative that is active at enrollment. The specific drug as well as dosage, frequency, and duration will be determined and titrated by the managing clinical team.
Alpha 2 agonist: Experimental	Drug: Dexmedetomidine Standard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00826553

Contacts

Contact: Matthew S King, MD	(615) 936-5967	matthew.king@vanderbilt.edu
Contact: Paula L Watson, MD	(615) 936-5146	paula.l.watson@vandebilt.edu

Locations

United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232

Sponsors and Collaborators

Vanderbilt University

More Information

No publications provided

Responsible Party:	Vanderbilt Medical Center ( Matthew S King, M.D. )
Study ID Numbers:	081170
Study First Received:	January 20, 2009
Last Updated:	January 21, 2009
ClinicalTrials.gov Identifier:	NCT00826553 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Vanderbilt University:

sedative
GABA
alpha 2 agonist
propofol
midazolam
lorazepam

dexmedetomidine
sleep
electroencephalogram
polysomnogram
ICU

Study placed in the following topic categories:

Neurotransmitter Agents
Adrenergic Agents
Psychotropic Drugs
Anesthetics
Adrenergic Agonists
Lorazepam
Signs and Symptoms
Respiratory Insufficiency
Respiratory Tract Diseases
Hypnotics and Sedatives
Dexmedetomidine
Analgesics
Propofol

Anesthetics, Intravenous
Tranquilizing Agents
Adrenergic alpha-Agonists
Respiration Disorders
Adjuvants, Immunologic
Central Nervous System Depressants
Midazolam
Anesthetics, General
Analgesics, Non-Narcotic
GABA Agonists
Anti-Anxiety Agents
Peripheral Nervous System Agents

Additional relevant MeSH terms:

Neurotransmitter Agents
Adrenergic Agents
Molecular Mechanisms of Pharmacological Action
GABA Modulators
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics
Adrenergic Agonists
Respiratory Insufficiency
Respiratory Tract Diseases
Sensory System Agents
Therapeutic Uses
Hypnotics and Sedatives
Analgesics
Dexmedetomidine

Propofol
Anesthetics, Intravenous
Adrenergic alpha-Agonists
Tranquilizing Agents
Respiration Disorders
Central Nervous System Depressants
Midazolam
Pharmacologic Actions
Adjuvants, Anesthesia
Anesthetics, General
Analgesics, Non-Narcotic
GABA Agonists
GABA Agents
Anti-Anxiety Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on May 06, 2009