UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Intravenous conscious sedation by use of midazolam during the examination of bronchoscopy
Title of the study (Brief title)	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	Yuichiro Takeda
Organization	National Center for Global health and Medicine
Division name	Department of Respiratory Medicine
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	Yuichiro Takeda
Organization	National Center for Global health and Medicine
Division name	Department of Respiratory Medicine
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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 06 Month 28 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	http://www.elsevier.com/locate/resinv
Results	Online publication in May 06 2018
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