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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01966315

Enrollment

Registered

2013-10-21

Start date

2013-10-31

Completion date

2016-12-31

Last updated

2019-04-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium, Poor Quality Sleep, Sleep Arousal Disorders, Sleep Deprivation

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

South Korea

Outcome results