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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000030135
Receipt No. 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 2019/03/29

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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
Email 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
Email hiroshi.takeda@sapmed.ac.jp

Sponsor
Institute Sapporo Medical University School of Medicine
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034410

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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