UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042635 |
|---|---|
| Receipt number | R000048601 |
| Scientific Title | Efficacy of addition of analgesic on disinhibition during bronchoscopy |
| Date of disclosure of the study information | 2020/12/03 |
| Last modified on | 2023/05/17 12:17:05 |
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Basic information
Public title
Efficacy of addition of analgesic on disinhibition during bronchoscopy
Acronym
Efficacy of addition of analgesic on disinhibition during bronchoscopy
Scientific Title
Efficacy of addition of analgesic on disinhibition during bronchoscopy
Scientific Title:Acronym
Efficacy of addition of analgesic on disinhibition during bronchoscopy
Region
| Japan |
Condition
Condition
Condition needed bronchoscopy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To investigate the efficacy on disinhibition during bronchoscopy when added analgesic
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Prevalence of disinhibition compared with that of previous study not using analgesic
Key secondary outcomes
Factors associated with disinhibiton
Association of satisfaction of bronchoscopy
Association of complication
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who are planned to undertake bronchoscopy
Key exclusion criteria
Patients who have difficulty with completing questionnaire
Patients who are considered as unfit by researchers
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsumoto |
Organization
Saiseikai-Noe Hospital
Division name
Department of Respiratory Medicine
Zip code
536-0001
Address
1-3-25, Furuichi, Jyoto-ku, Osaka
TEL
0669320401
mtakeshi@noe.saiseikai.or.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Matsumoto |
Organization
Saiseikai-Noe Hospital
Division name
Department of Respiratory Medicine
Zip code
536-0001
Address
1-3-25, Furuichi, Jyoto-ku, Osaka
TEL
0669320401
Homepage URL
mtakeshi@noe.saiseikai.or.jp
Sponsor or person
Institute
Saiseikai-Noe Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Saiseikai-Noe Hospital
Address
1-3-25, Furuichi, Jyoto-ku, Osaka
Tel
0669320401
yu.tsuruda@noe.saiseikai.or.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 | 12 | Month | 03 | 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
Completed
Date of protocol fixation
| 2020 | Year | 12 | Month | 03 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 02 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 03 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Cross-sectional study ; descriptive epidemiology
Management information
Registered date
| 2020 | Year | 12 | Month | 03 | Day |
Last modified on
| 2023 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048601
