UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Comparison of remifentanil and epidural anesthesia for Prevention of tachyarrhythmia after Pulmonary Resection
Title of the study (Brief title)	Comparison of remifentanil and epidural anesthesia for Prevention of tachyarrhythmia after Pulmonary Resection
Region	Japan

Condition
Condition	primary lung cancer
Classification by specialty	Chest surgery Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	We assess the the anti-tachyarrhythmic effect of remifentanil and epidural anesthesia in maintenance of anesthesia after pulmonary resection for primary lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of postoperative tachyarrhythmia
Key secondary outcomes	Major Adverse Cardiovascular and Cerebrovascular Event BNP,ANP,CK-MB,IL-6, Troponin,ACTH,cortisol,ADH,catecholamine fractionation, ghrelin

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Maneuver
Interventions/Control_1	To use of remifentanil in maintenance of anesthesia of pulmonary resection
Interventions/Control_2	To use of epidural anesthesia in maintenance of anesthesia of pulmonary resection
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	1. patients undergoing pulmonary resection 2. ASA-PS 1-3
Key exclusion criteria	1. patients with past of arrhythmia 2. ASA-PS > 3
Target sample size	80

Research contact person
Name of lead principal investigator	Kazumi Funaki
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Email	funapon1116@gmail.com

Public contact
Name of contact person	Kazumi Funaki
Organization	Tottori University
Division name	Division of Anesthesiology and Critical Care Medicine
Address	36-1, Nishi-cho, Yonago, Tottori, Japan
TEL	0859-38-6657
Homepage URL
Email	funapon1116@gmail.com

Sponsor
Institute	Division of Anesthesiology and Critical Care Medicin, Tottori University
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)

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	鳥取大学医学部附属病院（鳥取県）

Other administrative information
Date of disclosure of the study information	2013 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 03 Month 13 Day
Anticipated trial start date	2013 Year 04 Month 02 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2013 Year 04 Month 01 Day
Last modified on	2017 Year 04 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000012133