UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052606 |
|---|---|
| Receipt number | R000060008 |
| Scientific Title | The effect of local anesthetic administered during surgery on the atrial and ventricular pacing thresholds of permanent pacemakers |
| Date of disclosure of the study information | 2023/10/25 |
| Last modified on | 2025/04/27 13:16:30 |
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Basic information
Public title
The effect on pacemaker functional status of local anesthetic used during surgery
Acronym
The effect on pacemaker functional status of local anesthetic used during surgery
Scientific Title
The effect of local anesthetic administered during surgery on the atrial and ventricular pacing thresholds of permanent pacemakers
Scientific Title:Acronym
The effect of local anesthetic administered during surgery on the atrial and ventricular pacing thresholds of permanent pacemakers
Region
| Japan |
Condition
Condition
Patients with permanent pacemakers
Classification by specialty
| Cardiology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Patients with permanent pacemakers, like the general population, may receive local anesthetic during surgery. As part of their systemic effects, local anesthetic may affect cardiomyocytes and alter pacemaker thresholds. We investigate this possibility.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in atrial and/or ventricular pacing thresholds 30 min after local anesthetic administration
Key secondary outcomes
Identification of factors contributing to changes in atrial and/or ventricular pacing thresholds 30 min after local anesthetic administration (levobupivacaine plasma concentration, pH, Na, K, Cl, HCO3-)
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 with permanent pacemakers receiving local anesthetic under general anesthesia during surgery
Key exclusion criteria
Non-consenting patients
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Asuka |
| Middle name | |
| Last name | Kitajima |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
3308503
Address
1-847 Amanumacho, Omiyaku, Saitama, Japan
TEL
+8148-647-2111
a.kitajima@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Asuka |
| Middle name | |
| Last name | Kitajima |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
3308503
Address
1-847 Amanumacho, Omiyaku, Saitama, Japan
TEL
+8148-647-2111
Homepage URL
a.kitajima@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University Saitama Medical Center
Institute
Department
Personal name
Funding Source
Organization
Maruishi Pharmaceutical Co.,Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Jichi Medical University Bioethics Committee for Clinical Research, Saitama Medical Center
Address
1-847 Amanumacho, Omiyaku, Saitama, Japan
Tel
+8148-647-2111
a.kitajima@jichi.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
| 2023 | Year | 10 | Month | 25 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
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
No longer recruiting
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 08 | Month | 20 | Day |
Anticipated trial start date
| 2022 | Year | 03 | Month | 24 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Study design: Prospective observational study
Recruiting method: Patients who attended our center and met the inclusion criteria between 20 August 2022 and March 2025
Measurements: Pacing thresholds, plasma local anesthetic concentration and blood gas analysis (including pH, Na, K, Cl and HCO3-) will be measured at the following three time points:
(i) after induction of general anesthesia and before the surgery, (ii) at the end of the surgery and (iii) 30 minutes after local anesthetic administration.
The local anesthetic to be used is 0.25% levobupivacaine (0.25% popscaine) 3 mg/kg and the way of administration is ultrasound-guided peripheral nerve block. Blood samples should be taken from an arterial line placed after induction of general anesthesia.
Management information
Registered date
| 2023 | Year | 10 | Month | 25 | Day |
Last modified on
| 2025 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060008
