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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
Sponsor:
Information provided by (Responsible Party):
Seoul National University Hospital

Brief Summary:
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.

Condition or disease
Poor Quality Sleep Sleep Deprivation Sleep Arousal Disorders Delirium

Detailed Description:

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.


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Study Type : Observational
Actual Enrollment : 5 participants
Observational Model: Case-Control
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
Dexmedetomidine group

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

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.




Primary Outcome Measures :
  1. The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group [ Time Frame: during ICU stay ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Critical patients who take a sedative drugs (dexmedetomidine or midazolam).
Criteria

Inclusion Criteria:

  • sedation patients with dexmedetomidine or midazolam
  • over 18 years old

Exclusion Criteria:

  • Neurologic disease (stroke, seizure, dementia, hypoxic brain damage)
  • Brain infection
  • Alcoholics
  • Major Depression Disorder, Schizophrenia, Anxiety disorder
  • Hearing loss

Information from the National Library of Medicine

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


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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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

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Responsible Party: Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01966315     History of Changes
Other Study ID Numbers: B-1307/212-010
First Posted: October 21, 2013    Key Record Dates
Last Update Posted: April 23, 2019
Last Verified: December 2015

Additional relevant MeSH terms:
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Delirium
Sleep Deprivation
Sleep Arousal Disorders
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Dyssomnias
Sleep Wake Disorders
Parasomnias
Dexmedetomidine
Midazolam
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Adjuvants, Anesthesia
Anti-Anxiety Agents