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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000003971
Receipt No. R000004598
Scientific Title Prospective analysis of efficacy and safety of individualized administration of midazolam for sedation during bronchoscopy
Date of disclosure of the study information 2010/07/31
Last modified on 2011/06/12

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Basic information
Public title Prospective analysis of efficacy and safety of individualized administration of midazolam for sedation during bronchoscopy
Acronym Prospective analysis of midazolam administration for sedation during bronchoscopy
Scientific Title Prospective analysis of efficacy and safety of individualized administration of midazolam for sedation during bronchoscopy
Scientific Title:Acronym Prospective analysis of midazolam administration for sedation during bronchoscopy
Region
Japan

Condition
Condition Patients undergoing diagnostic bronchoscopy
Classification by specialty
Pneumology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the efficacy and safety of individualized administration of midazolam for sedation during bronchoscopy
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Phase II

Assessment
Primary outcomes Patient's discomfort during bronchoscopy
Key secondary outcomes Anxiety and memory during bronchoscopy, willingness to accept a repeat bronchoscopy, complications of the procedure, vital sign during bronchoscopy, time of bronchoscopy, dose of lidocaine, diagnostic rate

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 At the start
Male<=65y.o. female<=70 y.o. midazolam 0.075mg/kg
Male>65y.o. female>70 y.o. midazolam 0.05mg/kg
subsequent dose: half of the first dose q20min.
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 1) Patients who are going to undergo diagnostic bronchoscopy at the Nagoya University Hospital.
2) Patients aged 20 years or older
3) Patients able to fill out a questionnaire
4) Written informed consent from the patients
5) Adequate organ function, as follows:
AST/ALT <= 100 IU/L
T. Bil <= 1.5 mg/dL
Scr <= 1.5 mg/dL
SpO2 >= 90% or PaO2 >= 60 torr (room air )
Key exclusion criteria Patients with at least one of the following conditions are ineligible.
1) Patients with type II respiratory failure who take or need home oxygen therapy
2) Patients with obstructive sleep apnea syndrome who need positive airway pressure ventilation
3) History of myocardial infarction within 6 weeks
4) Having mental disorders unable to mutual understanding
5) History of grave drug allergic reaction or allergic reaction to midazolam
6) Acute angle-closure glaucoma
7) Neuromuscular disease (such as myasthenia gravis)
8) Patients who are taking
9) Pregnancy, breast feeding and suspected pregnancy
10) Inadequate for bronchoscopy
11) Patients whose participation in the trial is judged to be inappropriate by the attendeing doctor
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazuyoshi Imaizumi
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumai-cho, Showq-ku, Nagoya
TEL 052-744-2167
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kazuyoshi Imaizumi
Organization Nagoya University Graduate School of Medicine
Division name Department of Respiratory Medicine
Zip code
Address 65 Tsurumai-cho, Showa-ku, Nagoya
TEL 052-744-2167
Homepage URL
Email jeanluc@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University Graduate School of Medicine
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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 名古屋大学 医学部附属病院

Other administrative information
Date of disclosure of the study information
2010 Year 07 Month 31 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
2010 Year 04 Month 12 Day
Date of IRB
Anticipated trial start date
2010 Year 06 Month 01 Day
Last follow-up date
2011 Year 05 Month 01 Day
Date of closure to data entry
2011 Year 05 Month 01 Day
Date trial data considered complete
2011 Year 07 Month 01 Day
Date analysis concluded
2011 Year 08 Month 01 Day

Other
Other related information

Management information
Registered date
2010 Year 07 Month 30 Day
Last modified on
2011 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004598

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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