The Comparison of Dexmedetomidine and Midazolam for the Sleep in Intensive Care Unit

The Comparison of Dexmedetomidine and Midazolam for the Sleep of Mechanical Ventilated Intensive Care Unit Patients

Sponsors

Lead Sponsor: Seoul National University Hospital

Source 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.

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.

Overall Status Terminated
Start Date 2013-10-01
Completion Date 2016-12-01
Primary Completion Date 2016-03-01
Study Type Observational
Primary Outcome
Measure Time Frame
The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group during ICU stay
Enrollment 5
Condition
Eligibility

Sampling Method:

Probability Sample

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

Gender:

All

Minimum Age:

18 Years

Maximum Age:

N/A

Healthy Volunteers:

No

Overall Official
Last Name Role Affiliation
Young-Jae Cho, MPH Study Chair 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
Overall Contact Contact information is only displayed when the study is recruiting subjects.
Location
Facility: Seoul National University Bundang Hospital
Location Countries

Korea, Republic of

Verification Date

2015-12-01

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Dexmedetomidine group

Description: 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.

Label: Midazolam group

Description: 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.

Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

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