UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016448 |
|---|---|
| Receipt number | R000019106 |
| Scientific Title | The effects of propofol on the cardiac conduction system and the cardiac autonomic nervous system |
| Date of disclosure of the study information | 2015/02/05 |
| Last modified on | 2020/10/29 16:24:07 |
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Basic information
Public title
The effects of propofol on the cardiac conduction system and the cardiac autonomic nervous system
Acronym
The effects of propofol on the cardiac conduction system and the cardiac autonomic nervous system
Scientific Title
The effects of propofol on the cardiac conduction system and the cardiac autonomic nervous system
Scientific Title:Acronym
The effects of propofol on the cardiac conduction system and the cardiac autonomic nervous system
Region
| Japan |
Condition
Condition
Pediatric patients undergoing an electrophysiologic study and the radiofrequency catheter ablation
Classification by specialty
| Cardiology | Pediatrics | Anesthesiology |
| Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate dose-dependent effects of propofol on the cardiac conduction system and the cardiac autonomic nervous system.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sinus node recovery time
sinoatrial conduction time
atrial-His intervals
His-ventricular intervals
heart rate valiability analysis
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 continuous propofol infusion at a rate of 5mg/kg/h,2mg/kg of propofol is injected,followed by continuous infusion of propofol at a rate of 10mg/kg/h for 10min
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
| 3 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA physical status 1 and 2 pediatric patients who were scheduled undergoing
electrophysiologic study and radiofrequency catheter ablation for tachyarrhythmia
Key exclusion criteria
Patients with allergy to propofol and
its solvents
Patients with severe heart diseases
Patients with liver dysfunction
Patients with renal dysfunction
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Mayuka |
| Middle name | |
| Last name | Matsushima |
Organization
Kinki University Hospital,Faculty of
Medicine
Division name
Central operation department
Zip code
5898511
Address
377-2 Oono-higashi,Oosakasayama City,Oosaka,Japan
TEL
072-366-0221
m-shiba@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Mayuka |
| Middle name | |
| Last name | Matsushima |
Organization
Kinki University Faculty of Medicine
Division name
Deparment of Anesthesiology
Zip code
5898511
Address
377-2 Oono-higashi,Oosakasayama City,Oosaka,Japan
TEL
072-366-0221
Homepage URL
m-shiba@med.kindai.ac.jp
Sponsor or person
Institute
Deparment of Anesthesiology Kinki University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Deparment of Anesthesiology Kinki University Faculty of Medicine
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
Ethics Committee of Kindai University Faculty of Medicine
Address
377-2 Oono-higashi,Oosakasayama City,Oosaka,Japan
Tel
072-366-0221
gakumu@med.kindai.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
近畿大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 02 | Month | 05 | Day |
Related information
URL releasing protocol
https://doi.org/10.1111/jcpt.13302
Publication of results
Published
Result
URL related to results and publications
https://doi.org/10.1111/jcpt.13302
Number of participants that the trial has enrolled
23
Results
Results and discussion
Propofol significantly suppressed intrinsic cardiac HV conduction, but did not affect the SNRT, SACT or the AH interval. As HV blocks, which occur below the His bundle, are often life-threatening, the HV conduction delay may be a cause of severe AV blocks induced by propofol. Propofol directly suppressed parasympathetic nerve activity, and sympathetic nerve activity was also suppressed.
Results date posted
| 2020 | Year | 10 | Month | 29 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2020 | Year | 10 | Month | 24 | Day |
Baseline Characteristics
Twenty-three patients (age: 6-15 years; males: 16, females: 7) who were scheduled to undergo radiofrequency catheter ablation (RFCA) were prospectively enrolled in this study.
All of the patients had physical statuses of I or II according to the American Society of Anesthesiologists classification and apart from their cardiac arrhythmias were otherwise healthy
Participant flow
written informed consent from the parents of the patients.
The administration of all anti-arrhythmia drugs was stopped 2 days before the RFCA. The patients did not receive any premedication.
Adverse events
none
Outcome measures
sinus node recovery time
sinoatrial conduction time
atrial-His intervals
His-ventricular intervals
heart rate valiability analysis
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 11 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 11 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 08 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 08 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 08 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 08 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 02 | Month | 05 | Day |
Last modified on
| 2020 | Year | 10 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019106
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