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
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
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
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
