UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025385 |
|---|---|
| Receipt number | R000029226 |
| Scientific Title | SCH-01-2014 |
| Date of disclosure of the study information | 2016/12/23 |
| Last modified on | 2016/12/23 05:13:08 |
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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
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
thlee9@schmc.ac.kr
Sponsor or person
Institute
Soonchunhyang University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029226
