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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012860
Receipt No. R000015027
Scientific Title Effects of nicorandil on arterial oxygenation during one-ling ventilation
Date of disclosure of the study information 2014/01/15
Last modified on 2018/01/12

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Basic information
Public title Effects of nicorandil on arterial oxygenation during one-ling ventilation
Acronym Effects of nicorandil on arterial oxygenation during one-ling ventilation
Scientific Title Effects of nicorandil on arterial oxygenation during one-ling ventilation
Scientific Title:Acronym Effects of nicorandil on arterial oxygenation during one-ling ventilation
Region
Japan

Condition
Condition Patients scheduled for elective lung resection surgery
Classification by specialty
Chest surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We compare the effects of nicorandil and nitroglycerin on oxygenation during one-lung ventilation.
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Arterial oxygen tension (PaO2) during one-lung ventilation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved 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 In the nicorandil group, patients receive a continuous infusion of nicorandil.
Interventions/Control_2 In the nitrogrlycerin group, patients receive a continuous infusion of nitrogrlycerin.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients scheduled for elective lung resection surgery, with at least two pre-operative risk factors for ischemic heart disease.
Key exclusion criteria Patients on hemodialysis
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroaki Kawano
Organization Tokushima Prefectural Central Hospital
Division name Department of Anesthesiology
Zip code
Address 1-10-3 Kuramoto, Tokushima 770-8539, Japan
TEL 088-633-7151
Email hir.kawano@gmail.com

Public contact
Name of contact person
1st name
Middle name
Last name Hiroaki Kawano
Organization Tokushima Prefectural Central Hospital
Division name Department of Anesthesiology
Zip code
Address 1-10-3 Kuramoto, Tokushima 770-8539, Japan
TEL 088-633-7151
Homepage URL
Email hir.kawano@gmail.com

Sponsor
Institute Department of Anesthesiology, Tokushima Prefectural Central Hospital
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2014 Year 01 Month 15 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
2013 Year 10 Month 01 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 01 Month 15 Day
Last modified on
2018 Year 01 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015027

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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