UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007732 |
|---|---|
| Receipt number | R000009105 |
| Scientific Title | A randomized parallel-group trial of propofol versus midazolam for sadation during ERCP |
| Date of disclosure of the study information | 2012/04/30 |
| Last modified on | 2013/04/12 22:19:59 |
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Basic information
Public title
A randomized parallel-group trial of propofol versus midazolam for sadation during ERCP
Acronym
A randomized trial of propofol sadation during ERCP
Scientific Title
A randomized parallel-group trial of propofol versus midazolam for sadation during ERCP
Scientific Title:Acronym
A randomized trial of propofol sadation during ERCP
Region
| Japan |
Condition
Condition
Biliopancreatic disorder
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of safety and efficacy of propofol sedation during ERCP compared to midazolam
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sedation efficacy rate
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
1. Propofol group: a slow initial intravenous bolus of 0.8 mg/kg and maintain a continuous infusion of 3 mg/kg/h
Interventions/Control_2
2. Midazolam group: an initial bolus of 0.06mg/kg and inremental doses of 0.03mg/kg at the time of need
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patient over age 20
2. Patient who is clinically indicated for ERCP for examination or treatment of biliopancreatic disorder
3. Patient who has agreed to conditions after receiving an explanation about the contents of the present clinical study and who has signed the consent form
Key exclusion criteria
1. Patients who are deemed inappropriate to sedation because of bad general ccondition
2. Patients with severe cardiovascular or respiratory disorder
3. Patients who have decompensated liver cirrhosis
4. Patients who have experienced a serious adverse effect by propofol or midazolam
5. Patient with known contraindications for propofol or midazolam
6. Pregnant or potentially pregnant women
7. Other patients who are in the opinion of the caring investigator unfit for enrollment in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Serikawa |
Organization
Hiroshima University hospital
Division name
Department of gastroenterology and metabolism
Zip code
Address
1-2-3 Kasumi, Minami-ku, Hiroshima, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Minami |
Organization
Hiroshima University hospital
Division name
Department of gastroenterology and metabolism
Zip code
Address
TEL
082-257-5192
Homepage URL
char-aznable@hiroshima-u.ac.jp
Sponsor or person
Institute
Hiroshima University hospital
Institute
Department
Personal name
Funding Source
Organization
Hiroshima University hospital
Organization
Division
Category of Funding Organization
Self funding
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
広島大学病院
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 04 | Month | 30 | 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
Terminated
Date of protocol fixation
| 2012 | Year | 04 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 12 | Day |
Last modified on
| 2013 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009105
