UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030135 |
|---|---|
| Receipt number | R000034410 |
| Scientific Title | The changes of regional brain saturation of oxygen during one lung ventilation under video assisted thoracic surgery |
| Date of disclosure of the study information | 2017/11/28 |
| Last modified on | 2021/05/31 09:54:49 |
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Basic information
Public title
The changes of regional brain saturation of oxygen during one lung ventilation under video assisted thoracic surgery
Acronym
The changes of regional brain saturation of oxygen during one lung ventilation under video assisted thoracic surgery
Scientific Title
The changes of regional brain saturation of oxygen during one lung ventilation under video assisted thoracic surgery
Scientific Title:Acronym
The changes of regional brain saturation of oxygen during one lung ventilation under video assisted thoracic surgery
Region
| Japan |
Condition
Condition
The patients planned lung or esophageal surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We would like to compare the changes of brain regional saturation of oxygen under total intravenous anesthesia by using propofol with that under general anesthesia by using desflurane
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relative change of brain regional saturation of oxygen between pre-one lung ventilation and post-that.
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
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The group that undergone total intravenous anesthesia with propofol and remifentanil.
Our study will be continued for 2 days.
Interventions/Control_2
The group that undergone general anesthesia with desflurane and remifentanil.
Our study will be continued for 2 days.
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
The patients planned lung or esophageal surgery
Key exclusion criteria
The patients that has difficulty in mutual understanding or disagree about this study or cannot be used propofol and desflurane
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mitsutaka |
| Middle name | |
| Last name | Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
060-8543
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | Takada |
| Middle name | |
| Last name | Hiroshi |
Organization
Hospital section
Division name
clinical study section
Zip code
060-8563
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
hiroshi.takeda@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Sapporo Medical University School of Medicine
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
Hospital section
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
Tel
011-611-2111
hiroshi.takeda@sapmed.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
| 2017 | Year | 11 | Month | 28 | 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
50
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
| 2017 | Year | 11 | Month | 09 | Day |
Date of IRB
| 2017 | Year | 11 | Month | 09 | Day |
Anticipated trial start date
| 2017 | Year | 12 | Month | 06 | Day |
Last follow-up date
| 2021 | 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
| 2017 | Year | 11 | Month | 27 | Day |
Last modified on
| 2021 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034410
