UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000016448
Receipt No. 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 (Ver. 9)

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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
Email 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
Email m-shiba@med.kindai.ac.jp

Sponsor
Institute Deparment of Anesthesiology Kinki University Faculty of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019106