UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000023139
Receipt No. 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 2017/05/21

* 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 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
Middle name
Last name Takeshi Suzuki
Organization Keio University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL 03-3353-1211
Email takeshi-su@a7.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takeshi Suzuki
Organization Keio University School of Medicine
Division name Department of Anesthesiology
Zip code
Address 35 Shinanomachi Shinjuku-ku Tokyo Japan
TEL 03-3353-1211
Homepage URL
Email takeshi-su@a7.keio.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

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
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
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 Enrolling by invitation
Date of protocol fixation
2016 Year 05 Month 31 Day
Date of IRB
Anticipated trial start date
2016 Year 08 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
2016 Year 07 Month 12 Day
Last modified on
2017 Year 05 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026619

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.