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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000023619
Receipt No. 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

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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
Email 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
Email s.okachi@med.nagoya-u.ac.jp

Sponsor
Institute Department of Respiratory Medicine
Nagoya University Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027185

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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