NCT01966315|TerminatedDMC
Study Stopped
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Sponsor study identifier
observational
5
1 country
1
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
March 2016
Actual (reported)Study Completion
December 2016
Actual (reported)The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography in critically ill patients. And the investigators also compare the incidence of delirium between the two groups.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
October 13, 2013
Actual (reported)October 21, 2013
Actual (reported)March 2016
Actual (reported)December 2016
Actual (reported)The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group
during ICU stay
Dexmedetomidine group is the patients who sedated with dexmedetomidine in intensive care unit. We will randomly allocate using www.randomizer.org. They will sedate at the level of RASS -2. The dose of dexmedetomidine will be 0.2-0.7ug/kg/hr.
Midazolam group is the patients who sedated with midazolam in intensive care unit. We will randomly allocate using www.randomizer.org. They will sedate at the level of RASS -2. The dose of midazolam will be 0.05-0.1 mg/kg/hr.
Critical patients who take a sedative drugs (dexmedetomidine or midazolam).
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707, South Korea
Young-Jae Cho, MPH
Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul National University Bundang Hospital, Gyeonggi, Republic of Korea
5 participants (actual enrollment reported by the registry).
First Submitted
October 13, 2013
First Posted
October 21, 2013
Study Start
October 2013
Date type not reportedThis date has not been verified as actual or estimated.
Impact of Various Sedation Regimens on the Incidence of Delirium
Contact the study team to confirm eligibility.
Primary Completion
March 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
April 23, 2019
Record last verified: 2015-12
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Source: ClinicalTrials.gov.
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