UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039801 |
|---|---|
| Receipt number | 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 | 2024/03/16 12:04:47 |
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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
Operating time, anesthesia time, respiratory complications, neurological complications, renal complication, arterial partial pressure of oxygen, arterial partial pressure of carbon dioxide, oxygen saturation, length of ICU stay, length of hospital stay, level of pain
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
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
yonodera@asahikawa-med.ac.jp
Sponsor or person
Institute
Asahikawa Medical University
Institute
Department
Personal name
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
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
69
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
No longer recruiting
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
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
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
| 2024 | Year | 03 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045393
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
