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

Sponsor:	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

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

Resource links provided by NLM:

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

U.S. FDA Resources

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:	December 2010
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: GABA agonist	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. Other Names: Typical GABA agonists include: 1) propofol 2) midazolam 3) lorazepam.
Experimental: Alpha 2 agonist	Drug: Dexmedetomidine Standard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team.

Arms

Assigned Interventions

Experimental: GABA agonist

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.

Other Names:

Typical GABA agonists include:
1) propofol
2) midazolam
3) lorazepam.

Experimental: Alpha 2 agonist

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: Paula L Watson, MD

615-322-3412

paula.l.watson@vandebilt.edu

Locations

United States, Tennessee
Vanderbilt University Medical Center	Recruiting
Nashville, Tennessee, United States, 37232
Contact: Paula L Watson, MD 615-322-3412 paula.l.watson@vanderbilt.edu
Principal Investigator: Paula L Watson, MD

Sponsors and Collaborators

Vanderbilt University

Investigators

Principal Investigator:

Paula L Watson, MD

Vanderbilt School of Medicine

More Information

No publications provided

Responsible Party:	Paula l. Watson, M.D., Vanderbilt University Medical Center
ClinicalTrials.gov Identifier:	NCT00826553 History of Changes
Other Study ID Numbers:	081170
Study First Received:	January 20, 2009
Last Updated:	October 13, 2010
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

Additional relevant MeSH terms:

Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases
Midazolam
Lorazepam
Hypnotics and Sedatives
Propofol
Dexmedetomidine
GABA Agonists
Adjuvants, Anesthesia
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Anxiety Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anticonvulsants
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on February 09, 2012