UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002826 |
|---|---|
| Receipt number | R000003448 |
| Scientific Title | Effects of anesthetics on intraoperative cerebral oxygen balance and postoperative cognitive outcome in patients undergoing lung surgery |
| Date of disclosure of the study information | 2009/12/02 |
| Last modified on | 2015/07/14 12:01:53 |
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Basic information
Public title
Effects of anesthetics on intraoperative cerebral oxygen balance and postoperative cognitive outcome in patients undergoing lung surgery
Acronym
COCOLUS
(Cerebral oxygenation and cognitive outcome for lung surgery)
Scientific Title
Effects of anesthetics on intraoperative cerebral oxygen balance and postoperative cognitive outcome in patients undergoing lung surgery
Scientific Title:Acronym
COCOLUS
(Cerebral oxygenation and cognitive outcome for lung surgery)
Region
| Japan |
Condition
Condition
lung surgery
Classification by specialty
| Chest surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
This study is conducted to investigate the effects of anesthetics on intraoperative cerebral oxygen balance and postoperative cognitive function in patients undergoing lung surgery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative cognitive dysfunction
Key secondary outcomes
Intraoperative cerebral oxygen balance
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
propofol
Interventions/Control_2
sevoflurane
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for elective lung surgery with ASA physical status 1-3
Key exclusion criteria
1) pumonary fibrosis, 2) pregnant or possibility of pregnant, 3)psychological disorder, 4) Mini-Mental State Examination < 24, 5)moderate liver or renal dysfunction, 6) coagulation disorder
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiko Kawaguchi |
Organization
Nara Medical University
Division name
Department of Anesthesiology,
Zip code
Address
840 shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
drjkawa@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junji Egawa |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
Address
840 shijo-cho, Kashihara, Nara, Japan
TEL
0744-22-3051
Homepage URL
jun.e@f7.dion.ne.jp
Sponsor or person
Institute
Department of Anesthesiology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Nara Medical University
Organization
Division
Category of Funding Organization
Other
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
奈良県立医科大学 附属病院
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 12 | Month | 02 | 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
| 2007 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 12 | Month | 02 | Day |
Last modified on
| 2015 | Year | 07 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003448
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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