UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002301 |
|---|---|
| Receipt number | 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 10:39:59 |
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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
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
Sponsor or person
Institute
Emergency and Critical Care Medicine
Tokushima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002810
