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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002301
Receipt No. R000002810
Scientific Title Effects of dexmedetomidine on sleep characteristics in mechanically ventilated patients.
Date of disclosure of the study information 2009/10/30
Last modified on 2011/08/06

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Basic information
Public title Effects of dexmedetomidine on sleep characteristics in mechanically ventilated patients.
Acronym Dexmedetomidine and sleep characteristics.
Scientific Title Effects of dexmedetomidine on sleep characteristics in mechanically ventilated patients.
Scientific Title:Acronym Dexmedetomidine and sleep characteristics.
Region
Japan

Condition
Condition Mechanically ventilated patients.
Classification by specialty
Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate if dexmedetomidine improves sleep characyeristics in mechanically ventilated patients, compared with midazolam.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes sleep characteristics
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Dexmedetomidine as a night sedation
Interventions/Control_2 Midazolam as a night sedation
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The patients who are intubated and expected to receive mechanical ventilation at least 48 h in the ICU.
Key exclusion criteria Exclusion criteria were the presence of psychiatric illness, anoxic brain injury, suspected encephalopathy (drug overdose, hepatic failure), seizure disorder, and severe hemodynamic instability.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Oto
Organization Tokushima University Hospital
Division name Emergency and Critical Care Medicine
Zip code
Address 3-18-15 Kuramoto-cho Tokushima city Tokushima Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Tokushima University Hospital
Division name Emergency and critical Care Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Emergency and Critical Care Medicine
Tokushima University Hospital
Institute
Department

Funding Source
Organization Emergency and Critical Care Medicine
Tokushima University Hospital
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2009 Year 10 Month 30 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
24-hour PSG was recorded in ten adult MV patients. Total sleep time (TST) during the 24-hour period was 11.4h. During the nighttime, the sleep architecture consisted of non rapid-eye movement (NREM) sleep stage 1 (median 28.9 % of TST), stage 2 (median 71.2 % of TST), stage 3+4 (median 0 % of TST), and REM sleep (median 0 % of TST). The median sleep time totaled 4.7 h during the 9 hour nighttime period and excessive sleep fragmentation was detected by a high frequency of arousal (median 9.3 /h).
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2009 Year 07 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 10 Month 01 Day
Last follow-up date
2011 Year 03 Month 01 Day
Date of closure to data entry
2011 Year 04 Month 01 Day
Date trial data considered complete
2011 Year 04 Month 01 Day
Date analysis concluded
2011 Year 04 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 08 Month 05 Day
Last modified on
2011 Year 08 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002810

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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