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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029180
Receipt No. R000033357
Scientific Title Effect of thoracic epidural anesthesia on QT dispersion
Date of disclosure of the study information 2017/09/19
Last modified on 2018/11/01

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Basic information
Public title Effect of thoracic epidural anesthesia on QT dispersion
Acronym Thoracic epidural anesthesia on QT dispersion
Scientific Title Effect of thoracic epidural anesthesia on QT dispersion
Scientific Title:Acronym Thoracic epidural anesthesia on QT dispersion
Region
Japan

Condition
Condition Patients with ASA physical status I or II aged 20-65 years who were scheduled to undergo thoracic surgery are studied.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 QT dispersion (QTD) is known as a predictor of ventricular dysrhythmia. To clarify the effect of thoracic epidural anesthesia on ventricular dysrhythmia, we evaluate QT and QTD before and after epidural injection.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Ten minutes after injection of epidural anesthetics, QT and QT dispersion (QTD) in 12-lead electrocardiogram are recorded every minute.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After insertion of thoracic epidural catheter, patients take a rest for 5 minutes. Before injection, we record 12-leads ECGs. One minute after catheter injection of 7ml mepivacaine, we record ECGs every minute for 10 minutes.
Interventions/Control_2
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
65 years-old >=
Gender Male and Female
Key inclusion criteria Patients with ASA physical status I or II aged 20-65 years who were scheduled to undergo thoracic surgery were studied. QT and QTc interval must be less than 440msec.
Key exclusion criteria All patients with dysrhythmia, anticoagulants were excluded. Patients who can not hold a position for edidural injection are also excluded.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shigeki Yamaguchi
Organization Dokkyo Medical University
Division name Department of Anesthesiology
Zip code
Address 880 Kitaobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Email takasusu@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Toshifumi Takasusuki
Organization Dokkyo Medical University
Division name Department of Anesthesiology
Zip code
Address 880 Kitakobayashi, Mibu, Tochigi, Japan
TEL 0282-86-1111
Homepage URL
Email takasusu@dokkyomed.ac.jp

Sponsor
Institute Dokkyo Medical University
Institute
Department

Funding Source
Organization Dokkyo Medical University
Organization
Division
Category of Funding Organization Other
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
2017 Year 09 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

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
2017 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 09 Month 19 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
2017 Year 09 Month 18 Day
Last modified on
2018 Year 11 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033357

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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