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

NCT01966315 | Terminated DMC

• 1 other identifier: B-1307/212-010
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Poor Quality Sleep; Sleep Deprivation; Sleep Arousal Disorders; Delirium

Outcome Measures

Primary Outcomes (1)

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

  during ICU stay

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• sedation patients with dexmedetomidine or midazolam
• over 18 years old

You may not qualify if:

• Neurologic disease (stroke, seizure, dementia, hypoxic brain damage)
• Brain infection
• Alcoholics
• Major Depression Disorder, Schizophrenia, Anxiety disorder
• Hearing loss

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Sleep Deprivation; Sleep Arousal Disorders; Delirium

Condition Hierarchy (Ancestors)

Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders; Parasomnias; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders

Study Officials

• 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 CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 13, 2013
• First Posted: October 21, 2013
• Study Start: October 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: April 23, 2019

Record last verified: 2015-12

Locations

KR (1)