UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Research of memory during sedation in volunteers
Title of the study (Brief title)	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	Satoshi Hagihira
Organization	Osaka University Gaduate School of Medicine
Division name	Department of Anesthesiology and Intensive Care Medicine
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	Satoshi Hagihira
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anesthesiology and Intensive Care Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 18 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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