UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012860 |
|---|---|
| Receipt number | 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 12:39:19 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
hir.kawano@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Tokushima Prefectural Central Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015027
