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Clinical Trials/NCT01966315
NCT01966315TerminatedNot Applicable

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

Seoul National University Hospital1 site in 1 country5 target enrollmentStarted: October 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Terminated
Enrollment
5
Locations
1
Primary Endpoint
The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

The differences of sleep stage, sleep efficiency, arousal index and delirium between dexmedetomidine group and midazolam group

Time Frame: during ICU stay

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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