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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000039801
Receipt No. R000045393
Scientific Title Investigation of factors associated with adverse events during sedation with nerve block
Date of disclosure of the study information 2020/03/13
Last modified on 2020/03/13

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Basic information
Public title Investigation of factors associated with adverse events during sedation with nerve block
Acronym Investigation of factors associated with adverse events during sedation with nerve block
Scientific Title Investigation of factors associated with adverse events during sedation with nerve block
Scientific Title:Acronym Investigation of factors associated with adverse events during sedation with nerve block
Region
Japan

Condition
Condition Peripheral Arterial Disease
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this present study is to evaluate the adverse effect during sedation with peripheral nerve block.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The ratio of occurrence of hypoxia
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
100 years-old >=
Gender Male and Female
Key inclusion criteria Patients who underwent bypass surgery by peripheral artery disease were enrolled.
Key exclusion criteria Refusal to participate
Target sample size 500

Research contact person
Name of lead principal investigator
1st name Yoshiko
Middle name
Last name Onodera
Organization Asahikawa Medical University Hospital
Division name Surgical Operation Department
Zip code 078-8510
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL 0166-68-2583
Email yonodera@asahikawa-med.ac.jp

Public contact
Name of contact person
1st name Yoshiko
Middle name
Last name Onodera
Organization Asahikawa Medical University Hospital
Division name Surgical Operation Department
Zip code 078-8510
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
TEL 0166-68-2583
Homepage URL
Email yonodera@asahikawa-med.ac.jp

Sponsor
Institute Asahikawa Medical University
Institute
Department

Funding Source
Organization None
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 Asahikawa Medical University Research Ethics Committee
Address Midorigaoka-higashi 2-1-1-1, Asahikawa, Hokkaido, 078-8510, Japan
Tel 0166-68-2297
Email rs-kk.g@asahikawa-med.ac.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
2020 Year 03 Month 13 Day

Related information
URL releasing protocol
Publication of results Partially published

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 Enrolling by invitation
Date of protocol fixation
2019 Year 02 Month 10 Day
Date of IRB
2019 Year 03 Month 28 Day
Anticipated trial start date
2019 Year 03 Month 29 Day
Last follow-up date
2024 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information The occurrence rate of hypoxia is investigated from anesthesia record.

Management information
Registered date
2020 Year 03 Month 13 Day
Last modified on
2020 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045393

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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