UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015577
Receipt number R000018047
Scientific Title Evaluation of discomfort level during bronchoscopic examination under fentanyl and midazolam for sedation
Date of disclosure of the study information 2014/11/19
Last modified on 2015/11/01 10:45:07

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Basic information

Public title

Evaluation of discomfort level during bronchoscopic examination under fentanyl and midazolam for sedation

Acronym

Evaluation of discomfort level during bronchoscopic examination under fentanyl and midazolam for sedation

Scientific Title

Evaluation of discomfort level during bronchoscopic examination under fentanyl and midazolam for sedation

Scientific Title:Acronym

Evaluation of discomfort level during bronchoscopic examination under fentanyl and midazolam for sedation

Region

Japan


Condition

Condition

Chest and Mediastinal Diseases

Classification by specialty

Pneumology

Classification by malignancy

Malignancy

Genomic information

NO


Objectives

Narrative objectives1

The objective of this study is evaluating of discomfort level during bronchoscopic examination under fentanyl and midazolam for sedation

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Phase II


Assessment

Primary outcomes

The rate in acceptance level of re-examination (Less than 2 evaluation phases over 5 evaluation phases .We perform a questionnaire survey with a visual analogue scale after bronchoscopic examination).


Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Bronchoscopic examination under fentanyl and midazolam for sedation

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

(a) Patients refered to bronchoscopic examination
(b) Patients refered to elective bronchoscopic examination
(c) Patients that have never had bronchoscopic examination
(d) Performance status(less than 3)
(e) Patinets obtaining mental condition in questionnaire survey
(f) Informed consent
(g) Patients that take no opioid

Key exclusion criteria

(a) Contraindication for bronchoscopic examination
(b) Patients that have ever had been allergic to some medicine
(c) Mental difficulties in this study
(d) Other presumed difficulties for patients in this study

Target sample size

37


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Katsuyuki Kiura

Organization

Okayama University Hospital

Division name

Allergy and Respiratory Medicine

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama city, 700- 8558 Japan

TEL

086-235-7227

Email

kkiura@md.okayama-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Daisuke Minami

Organization

Okayama University Hospital

Division name

Palliative and Supportive Medicine

Zip code


Address

2-5-1 Shikata-cho, Kita-ku, Okayama city, 700- 8558 Japan

TEL

086-235-7227

Homepage URL


Email

d-minami@bj8.so-net.ne.jp


Sponsor or person

Institute

Okayama University Hospital Allergy and Respiratory Medicine

Institute

Department

Personal name



Funding Source

Organization

Okayama University Hospital Allergy and Respiratory medicine

Organization

Division

Category of Funding Organization

Other

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

2014 Year 11 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

Completed

Date of protocol fixation

2014 Year 11 Month 19 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 19 Day

Last follow-up date

2015 Year 10 Month 31 Day

Date of closure to data entry

2015 Year 10 Month 31 Day

Date trial data considered complete

2015 Year 10 Month 31 Day

Date analysis concluded

2015 Year 10 Month 31 Day


Other

Other related information



Management information

Registered date

2014 Year 11 Month 01 Day

Last modified on

2015 Year 11 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018047


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name