UMIN-CTR Clinical Trial

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
Email	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
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	Ethics committee of Keio University School of Medicine
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
Tel	03-3353-1211
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026619