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

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01966315
• Other study ID #: B-1307/212-010
• Status: Terminated
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: December 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: December 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Poor Quality Sleep
• Sleep Arousal Disorders
• Sleep Deprivation

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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