UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011010 |
|---|---|
| Receipt number | R000012881 |
| Scientific Title | Salivary amylase stress analysis; sedation with midazolam during bronchoscopy |
| Date of disclosure of the study information | 2013/06/19 |
| Last modified on | 2016/12/21 11:11:01 |
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Basic information
Public title
Salivary amylase stress analysis; sedation with midazolam during bronchoscopy
Acronym
Salivary amylase stress analysis; sedation with midazolam during bronchoscopy
Scientific Title
Salivary amylase stress analysis; sedation with midazolam during bronchoscopy
Scientific Title:Acronym
Salivary amylase stress analysis; sedation with midazolam during bronchoscopy
Region
| Japan |
Condition
Condition
Subjects of bronchoscopy; cases of suspected to malignant disease
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Consider the following items in order to implement safer bronchoscopy.
1.measuring biomarkers (salivary amylase) to examine the stress of bronchoscopy
2.measuring Bispectral Index (BIS) and electromyography (EMG) to examine the degree of sedation
3.conducting a survey patients after bronchoscopy to examine the degree of patient distress
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1.salivary amylase levels before and after bronchoscopy
2. Bispectral Index (BIS) and electromyography (EMG) during bronchoscopy
3.patient pain questionnaire after bronchoscopic
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
YES
Dynamic allocation
Institution consideration
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Interventions; sedation with midazolam during bronchoscopy.
Interventions/Control_2
Control; not use midazolam.
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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. subject of a bronchoscopy
2. cases written informed consent was obtained
3. cases of suspected to malignant disease
Key exclusion criteria
patients who were deemed inappropriate to the subject of this study by attending physician
Target sample size
110
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | takamasa hotta |
Organization
Shimane University Faculty of Medicine
Division name
Department of Biochemistry
Zip code
Address
89-1 Enya-cho Izumo Shimane 693-8501 JAPAN
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Shimane University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine
Zip code
Address
TEL
Homepage URL
hotta.takamasa@gmail.com
Sponsor or person
Institute
Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Division of Medical Oncology and Respiratory Medicine
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
Address
Tel
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
| 2013 | Year | 06 | Month | 19 | 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
Terminated
Date of protocol fixation
| 2013 | Year | 04 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 06 | Month | 19 | Day |
Last modified on
| 2016 | Year | 12 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012881
| 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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