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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025403
Receipt No. R000029241
Scientific Title Research of memory during sedation in volunteers
Date of disclosure of the study information 2016/12/27
Last modified on 2017/01/09

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Basic information
Public title Research of memory during sedation in volunteers
Acronym Memory and perception during sedation
Scientific Title Research of memory during sedation in volunteers
Scientific Title:Acronym Memory and perception during sedation
Region
Japan

Condition
Condition non objective disease
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of the study is to know the influence of sedation on several kinds of memry tasks in each sedation level. The final purpose is to develope a monitoring method to prevent awareness during anesthesia.
Basic objectives2 Others
Basic objectives -Others Another purpose of the study is to know the influence of sedation on some sensory perception and physiological responses in each sedation level.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Evaluation of the scores for several memory tests in each sedation level.
Key secondary outcomes Evaluation of several sensory perception and physiological responses in each sedation level.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Dose comparison
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 Use propofol or midazolam for sedation.
Interventions/Control_2 Control the sedation level in each participant based on the EEG monitoring and pharcokinetic and pharmacodynamic information.
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
20 years-old <=
Age-upper limit
40 years-old >
Gender Male
Key inclusion criteria Healthy male volunteers, without any disease and medications.
Key exclusion criteria except for inclusion criteria
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Hagihira
Organization Osaka University Gaduate School of Medicine
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka
TEL 06-6879-3133
Email hagihira@anes.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Satoshi Hagihira
Organization Osaka University Graduate School of Medicine
Division name Department of Anesthesiology and Intensive Care Medicine
Zip code
Address 2-2 Yamadaoka, Suita City, Osaka
TEL 06-6879-3133
Homepage URL
Email hagihira@anes.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Minisrty of Education, Culture, Sports, Science, and Technology, Japan
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2016 Year 12 Month 27 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
2013 Year 03 Month 18 Day
Date of IRB
Anticipated trial start date
2013 Year 05 Month 01 Day
Last follow-up date
2014 Year 03 Month 01 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 26 Day
Last modified on
2017 Year 01 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029241

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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