UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023139 |
|---|---|
| Receipt number | R000026619 |
| Scientific Title | Evaluation of the effect of epidural anesthesia on aute lung injury induced by one lung ventilation in patients undergoing lobectomy for lung cancer |
| Date of disclosure of the study information | 2016/07/21 |
| Last modified on | 2021/09/24 10:41:07 |
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Basic information
Public title
Evaluation of the effect of epidural anesthesia on aute lung injury induced by one lung ventilation in patients undergoing lobectomy for lung cancer
Acronym
The effect of epidural anesthesia on acute lung injury induced by one lung ventilation
Scientific Title
Evaluation of the effect of epidural anesthesia on aute lung injury induced by one lung ventilation in patients undergoing lobectomy for lung cancer
Scientific Title:Acronym
The effect of epidural anesthesia on acute lung injury induced by one lung ventilation
Region
| Japan |
Condition
Condition
lung cancer
Classification by specialty
| Chest surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the protective effect of epidural anesthesia on acute lung injury induced by one lung ventilation in patients undergoing lobectomy for lung cancer
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The concentration of IL-6 in epithelial lining fluid (ELF) of respiratory tract mucosa
Key secondary outcomes
The concentrations of other inflammatory cytokines (TNF-alpha, IL-1beta, IL-8, IL-10) in ELF, plasma cytokine (TNF-alpha, IL-1beta, IL-6, IL-8, IL-10) and malondialdehyde concentrations, blood gas analysis, postoperative pulmonary complications and organ injuries, postoperative pain evaluated by numerical rating scale, and the length of hospital stay
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Epidural anesthesia using 0.25% levobupivacain during one lung ventilation in patients undergoing lung resection surgeries for lung cancer
Interventions/Control_2
Continouos intravenous infusion of remifentanyl (0.5-1.0 microgram/kg/min) during one lung ventilation in patients undergoing lung resection surgeries for lung cancer
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
Patients with ASA status 1 or 2 over 20 years old, who was scheduled for lung resection surgery
Key exclusion criteria
Heart disease with NYHA 2-4
PaO2 less than 60mmHg under room air
FEV1.0% less than 50%
Platelet count less than 100000/mm3
Coagulation disorder (PT-INR > 1.5)
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Takeshi |
| Middle name | |
| Last name | Suzuki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL
03-3353-1211
takeshi-su@a7.keio.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Suzuki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL
03-3353-1211
Homepage URL
takeshi-su@a7.keio.jp
Sponsor or person
Institute
Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio 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
Ethics committee of Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
Tel
03-3353-1211
med-rinri-jimu@adst.keio.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
| 2016 | Year | 07 | Month | 21 | 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
Main results already published
Date of protocol fixation
| 2016 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2020 | 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
| 2016 | Year | 07 | Month | 12 | Day |
Last modified on
| 2021 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026619
