Overview

This trial is active, not recruiting.

Conditions delirium, respiratory failure
Treatments dexmedetomidine, gaba agonist
Sponsor Vanderbilt University
Start date January 2009
End date December 2013
Trial size 30 participants
Trial identifier NCT00826553, 081170

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Arm
(Experimental)
gaba agonist Typical GABA agonists include:
Patients sedated with GABA agonists (e.g. propofol, benzodiazepines) 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.
(Experimental)
dexmedetomidine
Standard of care sedative. Dosage, frequency, and duration will be determined by the managing clinical team.

Primary Outcomes

Measure
Time spent in standard sleep stages (N1, N2, N3, REM).
time frame: 4 days

Secondary Outcomes

Measure
Time spent in atypical sleep.
time frame: 4 days
Presence of burst suppression.
time frame: 4 days

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Comparison of Polysomnographic Findings in Mechanically Ventilated Patients Sedated With α2 Agonists Versus GABA Agonists
Principal investigator Paula L Watson, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Vanderbilt University.