UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023619 |
|---|---|
| Receipt number | R000027185 |
| Scientific Title | Safety and efficacy of sedation with midazolam during bronchoscopy |
| Date of disclosure of the study information | 2016/12/01 |
| Last modified on | 2016/09/29 14:32:49 |
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Basic information
Public title
Safety and efficacy of sedation with midazolam during bronchoscopy
Acronym
Sedation with midazolam during bronchoscopy
Scientific Title
Safety and efficacy of sedation with midazolam during bronchoscopy
Scientific Title:Acronym
Sedation with midazolam during bronchoscopy
Region
| Japan |
Condition
Condition
Respiratory disease, which is an indication of flexible bronchoscopy
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
YES
Objectives
Narrative objectives1
To identify factors affecting the efficacy and safety of sedation with midazolam during bronchoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Occurrence rate of hypoxemia during bronchoscopy
Key secondary outcomes
1. Blood concentrations of midazolam (after the initial dose, after adding administration)
2. MOAA/S scale
3. The bispectral index (BIS)
4. Questionnaire about the sedation
5. Adverse events
6. Correlation between gene polymorphism and efficacy or safety of sedation
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Patients undergoing bronchoscopy in Nagoya University Hospital
2. Age is 20 years or older
3. Written consent for participation in the study from the patient himself has been obtained
4. Patient with mental state that can enforce the investigation by questionaire
5. Laboratory test values within the preceding 14 days registration meets the following criteria:
a) AST / ALT < 3 times the facility references value upper limit
b) 1.5 times the total bilirubin value < facility reference value upper limit
c) following serum creatinine 1.5mg / dl
d) SpO2 > 90% in the room air
Key exclusion criteria
1. Patients with SpO2 <90% in the room air
2. There is a history of severe drug hypersensitivity, including hypersensitivity to midazolam
3. Patients with a neuromuscular disease
4. Patients with acute angle-closure glaucoma
5. Patients with myocardial infarction within-onset 6 weeks
6. Patients with other serious complications
7. Patients whom the attending physician has determined to be inappropriate as a subject of the present study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinori Hasegawa |
Organization
Nagoya University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2167
yhasega@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shotaro Okachi |
Organization
Nagoya University Hospital
Division name
Department of Respiratory Medicine
Zip code
Address
65 Tsurumai-cho, Showa-ku, Nagoya
TEL
052-744-2167
Homepage URL
s.okachi@med.nagoya-u.ac.jp
Sponsor or person
Institute
Department of Respiratory Medicine
Nagoya University Hospital
Institute
Department
Personal name
Funding Source
Organization
JSPS(Japan Society for promotion of Science)
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2016 | Year | 12 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2016 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 12 | 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
We enroll patients who are scheduled to undergo bronchoscopy at Nagoya University Hospital from December, 2016 to December, 2018, and meet eligibility criteria. We assess oxygen saturation, blood pressure, heart rate, BIS level, MOAA/S, questionnaire after procedure, adverse events.
Management information
Registered date
| 2016 | Year | 08 | Month | 14 | Day |
Last modified on
| 2016 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027185
