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

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.

Study Overview

• Status: Terminated
• Conditions: Delirium; Sleep Deprivation; Poor Quality Sleep; Sleep Arousal Disorders

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.

• Study Type: Observational
• Enrollment (Actual): 5

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Critical patients who take a sedative drugs (dexmedetomidine or midazolam).

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group	during ICU stay

Collaborators and Investigators

• Sponsor: Seoul National University Hospital
• Investigators: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): March 1, 2016
• Study Completion (Actual): December 1, 2016

Study Registration Dates

• First Submitted: October 13, 2013
• First Submitted That Met QC Criteria: October 16, 2013
• First Posted (Estimate): October 21, 2013

Study Record Updates

• Last Update Posted (Actual): April 23, 2019
• Last Update Submitted That Met QC Criteria: April 21, 2019
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Dyssomnias; Sleep Wake Disorders; Neurologic Manifestations; Parasomnias; Sleep Deprivation; Sleep Arousal Disorders
• Other Study ID Numbers: B-1307/212-010