UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000005547
Receipt number R000006576
Scientific Title Intravenous conscious sedation by use of midazolam during the examination of bronchoscopy
Date of disclosure of the study information 2011/05/06
Last modified on 2018/05/09 16:17:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information

Public title

Intravenous conscious sedation by use of midazolam during the examination of bronchoscopy

Acronym

Bronchoscopy under the conscious sedation by midazolam

Scientific Title

Intravenous conscious sedation by use of midazolam during the examination of bronchoscopy

Scientific Title:Acronym

Bronchoscopy under the conscious sedation by midazolam

Region

Japan


Condition

Condition

Patients for indication of bronchoscopic observation or procedure on central bronchial lesion.

Classification by specialty

Pneumology

Classification by malignancy

Others

Genomic information

YES


Objectives

Narrative objectives1

To know the appropriate administration of midazolam for intravenous conscious sedation under examination of bronchoscopy

Basic objectives2

Others

Basic objectives -Others

To find the factors affecting the dose and usage of midazolam

Trial characteristics_1

Exploratory

Trial characteristics_2

Explanatory

Developmental phase

Not applicable


Assessment

Primary outcomes

1)Pharmacokinetics (a total of 9 points)
2)Ramsay sedative score (before and after bronchoscopy)
3)Visual analog scale(VAS)on Bronchoscopy
4)Adverse effect and safety

Key secondary outcomes

a)Relationship between pharmacokinetics and genetic polymorphism
b) Relationship between pharmacokinetics and tolerance during bronchoscopy


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

Treatment

Type of intervention

Medicine

Interventions/Control_1

After premedication for examination of bronchoscopy(BF), 0.03 mg/kg of midazolam is administered intravenously for 2 min. Blood sample is taken at 9 time points for pharmacokinetics. Ramsay sedative score is evaluated at the start and the end of BF. After examination, each patient answers visual analog scale(VAS)on BF.

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

80 years-old >

Gender

Male and Female

Key inclusion criteria

1)Patient is suitable for bronchoscopic observation and procedure on central bronchial disease.
2)Age is more than and equal to 20 years.
3)Eastern Cooperative Oncology Group performance status of 0-3
4)Adequate pulmonary and cardiac function
Pulmonary function;
pO2; more than and equal to 70 torr
pCO2; more than and equal to 50 torr
FEV1.0; more than and equal to 1.0 L
BNP;more than and equal to 1.5 mg/d
Ejection Fraction; more than and equal to 50%
5)Adequate renal and hepatic function
Liver; Aspartate aminotransferase and alanine aminotransferase levels; below 2 times of upper limits of normal level
total bilirubin level; less than and equal to 3.0 mg/dl
Kidney;Creatinine; < 2.0 mg/dL
Creatinine clearance; more than and equal to 50 ml/min
BUN ; less than and equal to 25 mg/dl
6)Written informed consent

Key exclusion criteria

1)History of severe allergic reaction of midazolam
2)Contraindication of midazolam
3)Contraindication or relative contraindication of bronchoscopy
Respiratory diseases
Chronic respiratory failure type II
Symptomatic vena cava syndrome
Cardiac diseases
Uncontrolled cardiac failure
Myocardial ischemia or unstable angina
within 8 weeks
Uncontrolled arrhythmia
Renal diseases
Renal failure treated by hemodialysis
Central Nervous system
Cerebrovascular diseases within 8 weeks
Hepatic diseases
Liver cirrhosis with Child's C
Fulminant hepatitis
Hepatic failure
4)History of severe allergic reaction of local anesthesia (xylocaine)
5)Pregnant status or lactation
6)Psychic disease or status
7)Evidence of HIV infection
8)Other ineligible status judged by physicians

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yuichiro Takeda

Organization

National Center for Global health and Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

TEL

03-3202-7181

Email

ytakeda@hosp.ncgm.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yuichiro Takeda

Organization

National Center for Global health and Medicine

Division name

Department of Respiratory Medicine

Zip code


Address

1-21-1 Toyama, Shinjuku-ku, Tokyo, 162-8655, Japan

TEL

03-3202-7181

Homepage URL


Email

ytakeda@hosp.ncgm.go.jp


Sponsor or person

Institute

Department of Respiratory Medicine
National Center for Global health and Medicine

Institute

Department

Personal name



Funding Source

Organization

The Grantof National Center for Global Health and Medicine(23-113)

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Department of drug metabolism and disposition
Meiji pharmaceutical university

Name of secondary funder(s)

None


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

国立国際医療研究センター病院(東京都)


Other administrative information

Date of disclosure of the study information

2011 Year 05 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


Result

URL related to results and publications

http://www.elsevier.com/locate/resinv

Number of participants that the trial has enrolled


Results

Online publication in May 06 2018

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

2008 Year 06 Month 28 Day

Date of IRB


Anticipated trial start date

2008 Year 10 Month 01 Day

Last follow-up date

2013 Year 06 Month 30 Day

Date of closure to data entry

2013 Year 10 Month 01 Day

Date trial data considered complete

2013 Year 10 Month 01 Day

Date analysis concluded

2013 Year 12 Month 31 Day


Other

Other related information



Management information

Registered date

2011 Year 05 Month 02 Day

Last modified on

2018 Year 05 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006576


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name