UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000025403
Receipt number 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 10:29:19

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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 or person

Institute

Osaka University Graduate School of Medicine

Institute

Department

Personal name



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

Value
https://center6.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