UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032468 |
|---|---|
| Receipt number | R000037020 |
| Scientific Title | Prospective randomized controlled trial on efficacy and safety by combined analgesics at sedative bronchoscopy using a BIS monitor |
| Date of disclosure of the study information | 2018/05/03 |
| Last modified on | 2018/11/01 11:57:38 |
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Basic information
Public title
Prospective randomized controlled trial on efficacy and safety by combined analgesics at sedative bronchoscopy using a BIS monitor
Acronym
Prospective randomized controlled trial on efficacy and safety by combined analgesics at sedative bronchoscopy using a BIS monitor
Scientific Title
Prospective randomized controlled trial on efficacy and safety by combined analgesics at sedative bronchoscopy using a BIS monitor
Scientific Title:Acronym
Prospective randomized controlled trial on efficacy and safety by combined analgesics at sedative bronchoscopy using a BIS monitor
Region
| Japan |
Condition
Condition
Peripheral lung lesion
Classification by specialty
| Pneumology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the additional effect on safety and patient's satisfaction with analgesics combined with sedative bronchoscopy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The patient satisfaction score 2 hours after bronchoscopy using a visual analogue scale (VAS)
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Diagnosis
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Administration of midazolam during bronchoscopy
Interventions/Control_2
Administration of midazolam and fentanyl during bronchoscopy
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Over 20 years old and under 90 years
2) Adaptation of bronchoscopy (EBUS-GS)
3) Written consent has been obtained
Key exclusion criteria
1) History of severe drug allergy
2) Contraindications to use of midazolam and fentanyl
3) Using any opioids
4) Severe hypoxemia or hypercapnia
5) History of severe heart, lung, liver, kidney, neuromuscular disease
6) History of epilepsy
7) History of symptomatic cerebral infarction
8) During pregnancy or possible pregnancy
9) Emergency procedure
10) Bronchoscopy other than EBUS-GS
11) Other conditions inappropriate for participating in the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naohiko Hamaguchi |
Organization
Ehime University School of Medicine
Division name
Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5303
guri0531@m.ehime-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takahide Kato |
Organization
Ehime University School of Medicine
Division name
Department of Cardiology, Pulmonology, Hypertension and Nephrology
Zip code
Address
Shitsukawa, Toon, Ehime
TEL
089-960-5303
Homepage URL
kato.takahide.tn@ehime-u.ac.jp
Sponsor or person
Institute
Ehime University
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
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
愛媛大学医学部附属病院（愛媛県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 05 | Month | 03 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 04 | Month | 23 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 05 | Month | 03 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 03 | Day |
Last modified on
| 2018 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037020
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
