UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000017076
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email hayasix0917@gmail.com

Sponsor
Institute Kanazawa University Hospital
Institute
Department

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
Email 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
URL(English) https://upload.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


Contact us.