UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017076 |
|---|---|
| Receipt number | R000019808 |
| Scientific Title | The usefulness and Safety of propofol for benzodiazepine resistance cases in endoscopic sedation |
| Date of disclosure of the study information | 2015/04/08 |
| Last modified on | 2019/05/10 09:42:49 |
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Basic information
Public title
The usefulness and Safety of propofol for benzodiazepine resistance cases in endoscopic sedation
Acronym
Propofol for benzodiazepine resistance cases in endoscopic sedation
Scientific Title
The usefulness and Safety of propofol for benzodiazepine resistance cases in endoscopic sedation
Scientific Title:Acronym
Propofol for benzodiazepine resistance cases in endoscopic sedation
Region
| Japan |
Condition
Condition
Disease that requires endoscopic procedures
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In performing an endoscopic procedure, to evaluate the usefulness and safety of propofol for the patient of benzodiazepine derivatives resistance in case of sedation.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Adverse events and safety in using propofol
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
We use propofol, if midazolam is insufficient in sedation.
Interventions/Control_2
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.Endoscopy procedures that required sedation.
2.More than 20 years of age.
3.ECOG Performance Status is 0 or 1.
4.There is no severe liver or kidney dysfunction.
5.No contraindication for propofol.
6.Have been obtained the consent of the study participants in the document.
Key exclusion criteria
1. Hypersensitivity history to propofol or formulation.
2. During pregnancy, during lactation.
3. ECOG-Performance Status is over 2 or more.
4. Advanced liver of kidney dysfunction.
5. Determined to be inappropriate to carry out the study.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | Shuichi |
| Middle name | |
| Last name | Kaneko |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
9208641
Address
Takaramachi 13-1, Kanazawa, Ishikawa, JAPAN
TEL
076-265-2235
skaneko@m-kanazawa.jp
Public contact
Name of contact person
| 1st name | Tomoyuki |
| Middle name | |
| Last name | Hayashi |
Organization
Kanazawa University Hospital
Division name
Department of Gastroenterology
Zip code
9208641
Address
Takaramachi 13-1, Kanazawa, Ishikawa, JAPAN
TEL
076-265-2235
Homepage URL
hayasix0917@gmail.com
Sponsor or person
Institute
Kanazawa University Hospital
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University Hospital
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
kanazawadaigaku
Address
takaramachi
Tel
0762652000
doctorugbyknzwtym@yahoo.co.jp
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
| 2015 | Year | 04 | Month | 08 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-bin/icdr/ctr_up_reg_f5.cgi
Publication of results
Unpublished
Result
URL related to results and publications
No
Number of participants that the trial has enrolled
10
Results
No
Results date posted
| 2019 | Year | 05 | Month | 10 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
No
Participant flow
No
Adverse events
No
Outcome measures
No
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2015 | Year | 04 | Month | 08 | Day |
Date of IRB
| 2015 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Transfer to JRCT
Management information
Registered date
| 2015 | Year | 04 | Month | 08 | Day |
Last modified on
| 2019 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019808
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
