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UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000007732
Receipt No. 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

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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
Email

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
Email char-aznable@hiroshima-u.ac.jp

Sponsor
Institute Hiroshima University hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009105

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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