UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039403 |
|---|---|
| Receipt number | R000044914 |
| Scientific Title | Comparison of the effect of desflurane and propofol on regional cerebral oxygen saturation during one lung ventilation: a randomized trial |
| Date of disclosure of the study information | 2020/03/04 |
| Last modified on | 2020/10/09 14:42:06 |
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Basic information
Public title
Comparison of the effect of anesthetic agents on regional cerebral oxygen saturation during one lung ventilation
Acronym
Regional cerebral oxygen saturation during one lung ventilation
Scientific Title
Comparison of the effect of desflurane and propofol on regional cerebral oxygen saturation during one lung ventilation: a randomized trial
Scientific Title:Acronym
Comparison of the effect of desflurane and propofol on regional cerebral oxygen saturation during one lung ventilation: a randomized trial
Region
| Japan |
Condition
Condition
Lobectomy, Surgery for Mediastinal tumors
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
a comparison between propofol and desflurane of regional cerebral oxygen saturation during one lung ventilation
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
decrease of regional cerebral oxygen saturation at 30 minutes after the start of one lung ventilation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
anesthetic agent: propofol
Interventions/Control_2
anesthetic agent: desflurane
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients who undergo lobectomy or surgery of mediastinal tumors with one lung ventilation at Gifu University Hospital
Key exclusion criteria
ASA-PSC greater than 3
interstitial pneumonia
past history of ischemic heart disease, heart failure and cerebrovascular disorder
unable communication
past history of lung segmentectomy or lobectomy
not appropriate in use of test drugs
Target sample size
36
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Iida |
Organization
Gifu University Graduate School of Medicine
Division name
Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu, 501-1194
TEL
058-230-6404
hayashiw@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Keishu |
| Middle name | |
| Last name | Hayashi |
Organization
Gifu University Graduate School of Medicine
Division name
Anesthesiology and Pain Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu City, Gifu, 501-1194
TEL
058-230-6404
Homepage URL
hayashiw@gifu-u.ac.jp
Sponsor or person
Institute
Gifu 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
The Institutional Review Board for Clinical Research of Gifu University
Address
1-1 Yanagido, Gifu City, Gifu
Tel
058-230-6059
rinri@gifu-u.ac.jp
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 03 | Month | 04 | 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
| 2020 | Year | 03 | Month | 04 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 16 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 02 | Month | 06 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044914
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
