The Comparison of Dexmedetomidine and Midazolam for the Sleep in Intensive Care Unit
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|ClinicalTrials.gov Identifier: NCT01966315|
Recruitment Status : Terminated (The portable PSG machine can not be available any more.)
First Posted : October 21, 2013
Last Update Posted : April 23, 2019
|Condition or disease|
|Poor Quality Sleep Sleep Deprivation Sleep Arousal Disorders Delirium|
Sleep is very important for cognitive and immune function. However, patients in intensive care unit (ICU) have a very poor sleep.
Almost all ventilated patients in intensive care unit (ICU) take a sedative drug. In Korea, most commonly used sedative drugs are dexmedetomidine and midazolam.
The investigators are going to compare the sleep quality and quantity between dexmedetomidine group and midazolam group using 24 hour polysomnography. And the investigators also compare the incidence of delirium between the two groups.
|Study Type :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||The Comparison of Dexmedetomidine and Midazolam for the Sleep of Mechanical Ventilated Intensive Care Unit Patients|
|Study Start Date :||October 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||December 2016|
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.
- The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group [ Time Frame: during ICU stay ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01966315
|Korea, Republic of|
|Seoul National University Bundang Hospital|
|Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707|
|Study Chair:||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|