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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002826
Receipt No. 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

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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
Email 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
Email jun.e@f7.dion.ne.jp

Sponsor
Institute Department of Anesthesiology, Nara Medical University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003448

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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