UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029180 |
|---|---|
| Receipt number | 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 15:00:55 |
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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
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
takasusu@dokkyomed.ac.jp
Sponsor or person
Institute
Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033357
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| Registered date | File name |
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| Registered date | File name |
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