UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013347 |
|---|---|
| Receipt number | R000015577 |
| Scientific Title | Evaluation of thoracic epidural anesthesia on postoperative cardiac repolarization |
| Date of disclosure of the study information | 2014/03/05 |
| Last modified on | 2023/09/12 22:00:28 |
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Basic information
Public title
Evaluation of thoracic epidural anesthesia on postoperative cardiac repolarization
Acronym
Thoracic epidural anesthesia on postoperative cardiac repolarization
Scientific Title
Evaluation of thoracic epidural anesthesia on postoperative cardiac repolarization
Scientific Title:Acronym
Thoracic epidural anesthesia on postoperative cardiac repolarization
Region
| Japan |
Condition
Condition
Patients scheduled for non-cardiac surgery under general anesthesia combined with thoracic epidural anesthesia
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of effects and safety of thoracic epidural anesthesia on postoperative cardiac repolarization
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
cardiac repolarization time on postoperative electrocardiography
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intraoperative epidural administration of levobupivacaine
Interventions/Control_2
no intraoperative epidural administration
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
Patients scheduled for non-cardiac surgery under general anesthesia combined with thoracic epidural anesthesia
Key exclusion criteria
Patients taking medication that affects to QT interval, having any cardiac rhythm other than sinus rhythm, or with a preoprative abnormal QT prolongation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Tadashi |
| Middle name | |
| Last name | Matsuura |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
Asahimachi 1-5-7, Abenoku, Osaka 545-8586, Japan
TEL
+81-6-6645-2186
t.matsuura@med.osaka-cu.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Hori |
Organization
Osaka City University Graduate School of Medicine
Division name
Department of Anesthesiology
Zip code
545-8586
Address
Asahimachi 1-5-7, Abenoku, Osaka 545-8586, Japan
TEL
+81-6-6645-2186
Homepage URL
k.hori@med.osaka-cu.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City University Graduate School of Medicine
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Research ethics committe, Osaka City University Graduate School of Medicine
Address
Asahimachi 1-2-7-601, Abenoku, Osaka
Tel
06-6645-3456
ethics@med.osaka-cu.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
| 2014 | Year | 03 | Month | 05 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fphar.2023.936242/full
Publication of results
Unpublished
Result
URL related to results and publications
https://www.frontiersin.org/articles/10.3389/fphar.2023.936242/full
Number of participants that the trial has enrolled
60
Results
The median postoperative corrected QT interval interval with 3 ml/h epidural levobupivacaine was significantly longer than that without epidural analgesia. Using multiple regression analysis for the factors known to affect postoperative corrected QT interval interval, epidural analgesia was found to be an independent variable for prolongation, and the mean difference of the corrected QT interval interval with or without epidural analgesia was 23 ms after adjustment.
Results date posted
| 2023 | Year | 09 | Month | 12 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of the patients was 71 (male/female 32/25), the medical history of whom were 4 coronary artery disease, 2 stroke and 17 diabets.The median surgical time was 224 min.
Participant flow
Patients were randomly allocated to two groups in a 1:1 ratio: an "Epidural Analgesia" group and a "No Epidural Analgesia" group. In both groups, an epidural catheter was inserted before induction of general anesthesia, but the epidural drug was administered only in the epidural analgesia group during surgery. The baseline QTc interval was recorded before the epidural tap, and postoperative QTc was recorded at the end of surgery following tracheal extubation.
Adverse events
None
Outcome measures
The postoperative QTc interval was used as the primary outcome to evaluate the potential risk of perioperative arrhythmogenicity.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2013 | Year | 07 | Month | 04 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 05 | Day |
Anticipated trial start date
| 2014 | Year | 03 | Month | 05 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 03 | Month | 05 | Day |
Last modified on
| 2023 | Year | 09 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015577
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