UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Safety and efficacy of sedation with midazolam during bronchoscopy
Title of the study (Brief title)	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	Yoshinori Hasegawa
Organization	Nagoya University Hospital
Division name	Department of Respiratory Medicine
Address	65 Tsurumai-cho, Showa-ku, Nagoya
TEL	052-744-2167
Email	yhasega@med.nagoya-u.ac.jp

Public contact
Name of contact person	Shotaro Okachi
Organization	Nagoya University Hospital
Division name	Department of Respiratory Medicine
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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