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

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 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


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

Value
https://center6.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