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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Total Enrollment

5 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

How Your Patients' Non-REM Sleep Changes On Sedatives in the Intensive Care Units

NCT00826553

Delirium Respiratory Failure

TERMINATED PHASE1

Dexmedetomidine Versus Midazolam for Continuous Sedation in the Intensive Care Unit (ICU)

NCT00481312

Continuous Sedation in Initially Sedated Adults in ICU

COMPLETED PHASE3

Reducing Days DELirious With DEXmedetomidine as Part of an Intensive Care Unit Sleep Promotion Bundle

NCT06824077

Sleep Delirium ICU Hospitalization

NOT_YET_RECRUITING EARLY_PHASE1

A Comparision of Midazolam-dexmedetomidine With Dexmedetomidine Alone for Hemodynamic Stability and Quality of Sedation in Elderly Patients Under Spinal Anesthesia

NCT01979653

Sedation; Aged; Hemodynamics

WITHDRAWN NA

Dexmedetomidine for Continuous Sedation

NCT00226785

Conscious Sedation

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Poor Quality Sleep Sleep Deprivation Sleep Arousal Disorders Delirium

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Young-Jae Cho, MPH

Role: STUDY_CHAIR

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