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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005547
Receipt No. 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

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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
Institute Department of Respiratory Medicine
National Center for Global health and Medicine
Institute
Department

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
URL(English) https://upload.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


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