UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041518 |
|---|---|
| Receipt number | R000047394 |
| Scientific Title | An observational study about the effect of epidural anesthesia on QT interval in postoperative ECG |
| Date of disclosure of the study information | 2020/08/22 |
| Last modified on | 2023/08/30 18:33:27 |
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Basic information
Public title
The effect of epidural anesthesia on QT interval in postoperative ECG
Acronym
Epidural anesthesia on QT interval in postoperative ECG
Scientific Title
An observational study about the effect of epidural anesthesia on QT interval in postoperative ECG
Scientific Title:Acronym
Epidural anesthesia on postoperative QT interval; An observational study
Region
| Japan |
Condition
Condition
Patients scheduled for non-cardiac surgery under general anesthesia combined with thoracic epidural analgesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Assessment of effects of thoracic epidural anesthesia on postoperative QT interval
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative corrected QT interval
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for non-cardiac surgery under general anesthesia combined with thoracic epidural analgesia
Key exclusion criteria
Patients having any cardiac rhythm other than sinus rhythm, or high-risk patients for general anesthesia (ASA Class greater than 2)
Target sample size
30
Research contact person
Name of lead principal investigator
| 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
TEL
+81-6-6645-2186
k.hori@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
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
+81-6-6645-3456
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
| 2020 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.frontiersin.org/articles/10.3389/fphar.2023.936242/full
Publication of results
Published
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
30
Results
The median postoperative QTc interval with 5 ml/h epidural levobupivacaine was significantly prolonged compared to baseline. Using the linear regression model, ephedrine dosage was detected as a significant independent variable, and the coefficient was 1.7 ms.
Results date posted
| 2023 | Year | 08 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
The median age of the patients was 72 (male/female 17/11), the medical history of whom were 1 coronary artery disease and 6 diabets.The median surgical time was 210 min.
Participant flow
An epidural catheter was inserted before induction of general anesthesia, and a test dose of 1% lidocaine (1.5 mL) with epinephrine (1:100,000) was used to confirm epidural catheter insertion. 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
Main results already published
Date of protocol fixation
| 2020 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 14 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Assessment of effects of thoracic epidural anesthesia with 5 ml/h levobupivacaine on postoperative QT interval
Management information
Registered date
| 2020 | Year | 08 | Month | 22 | Day |
Last modified on
| 2023 | Year | 08 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047394
