UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003971 |
|---|---|
| Receipt number | 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 07:40:12 |
* 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
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
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
jeanluc@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University Graduate School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.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 |
