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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025385
Receipt No. R000029226
Scientific Title SCH-01-2014
Date of disclosure of the study information 2016/12/23
Last modified on 2016/12/23

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Basic information
Public title SCH-01-2014
Acronym Midazolam versus propofol sedation during ERCP
Scientific Title SCH-01-2014
Scientific Title:Acronym Midazolam versus propofol sedation during ERCP
Region
Asia(except Japan)

Condition
Condition Finished
Classification by specialty
Gastroenterology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 sedation safety measurement by cardiopulmonary complications
Basic objectives2 Others
Basic objectives -Others Procedure outcomes
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Cardiopulmonary complications: hypoxia, hypotension, tachycardia, and bradycardia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Educational,Counseling,Training
Type of intervention
Other
Interventions/Control_1 Midazolam based sedation

Sedation safety and efficacy measurement according to the two protocol.
Interventions/Control_2 Propofol based sedation
Sedation safety and efficacy measurement according to the two protocol.
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
80 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Pancreatobiliary disease needing therapeutic ERCP
Key exclusion criteria Older than 80 years
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Taehoon Lee
Organization Soonchunhyang University Cheonan Hospital
Division name Gastroenterology
Zip code
Address 23-20 Bongmyung-dong, Cheonan-si, Chungcheongnam-do
TEL +82-41-570-3662
Email thlee9@schmc.ac.kr

Public contact
Name of contact person
1st name
Middle name
Last name Taehoon Lee
Organization Soonchunhyang University Cheonan Hospital
Division name Gastroenterology
Zip code
Address 23-20 Bongmyung-dong, Cheonan-si, Chungcheongnam-do
TEL +82-41-570-3662
Homepage URL
Email thlee9@schmc.ac.kr

Sponsor
Institute Soonchunhyang University
Institute
Department

Funding Source
Organization Soonchunhyang University
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
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 23 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 12 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
2016 Year 08 Month 06 Day
Date analysis concluded
2016 Year 09 Month 05 Day

Other
Other related information

Management information
Registered date
2016 Year 12 Month 23 Day
Last modified on
2016 Year 12 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029226

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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