UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006496 |
|---|---|
| Receipt number | R000007707 |
| Scientific Title | Comparison of cognitive function during dexmedetomidine or propofol infusion in health volunteer; Crossover study |
| Date of disclosure of the study information | 2011/10/17 |
| Last modified on | 2015/04/04 20:24:48 |
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Basic information
Public title
Comparison of cognitive function during dexmedetomidine or propofol infusion in health volunteer; Crossover study
Acronym
Comparison of cognitive function during dexmedetomidine or propofol infusion in health volunteer; Crossover study
Scientific Title
Comparison of cognitive function during dexmedetomidine or propofol infusion in health volunteer; Crossover study
Scientific Title:Acronym
Comparison of cognitive function during dexmedetomidine or propofol infusion in health volunteer; Crossover study
Region
| Japan |
Condition
Condition
healthy volunteer
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is comparison of cognitive function during dexmedetomidine or propofol infusion in health volunteer.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
cognitive function before and after drug infusion
Key secondary outcomes
Sedative score
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Dexmedetomidine
Interventions/Control_2
Propofol
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Normal subject
Key exclusion criteria
Taking any drungs
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoaki Yatabe |
Organization
Kochi University
Division name
Department of Anesthesiology
Zip code
Address
Kohasu, Oko-cho, Nankoku-city, Kochi,Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoaki Yatabe |
Organization
Kochi University
Division name
Department of Anesthesiology
Zip code
Address
Kohasu, Oko-cho, Nankoku-city, Kochi,Japan
TEL
Homepage URL
Sponsor or person
Institute
Kochi University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
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
高知大学医学部病院（高知県）
Kochi Medical School Hospital (Kochi)
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 17 | 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
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
| 2011 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 11 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 06 | Day |
Last modified on
| 2015 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007707
