UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008851 |
|---|---|
| Receipt number | R000010392 |
| Scientific Title | Effect of desflurane and propofol on cardiac electrophysiology |
| Date of disclosure of the study information | 2012/09/06 |
| Last modified on | 2017/09/09 19:20:11 |
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Basic information
Public title
Effect of desflurane and propofol on cardiac electrophysiology
Acronym
Effect of desflurane and propofol on cardiac electrophysiology
Scientific Title
Effect of desflurane and propofol on cardiac electrophysiology
Scientific Title:Acronym
Effect of desflurane and propofol on cardiac electrophysiology
Region
| Japan |
Condition
Condition
Tachyarrhythmia
Classification by specialty
| Cardiology | Pediatrics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of desflurane and propofol on cardiac electrophysiology in children undergoing radiofrequency catheter ablation for tachyarrthythmia
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
sinus node recovery time
Key secondary outcomes
sinoatrial conduction time, atrial-His conduction time, His bundle refractory time, accessory pathway effective refractory time
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
general anesthesia with propofol
Interventions/Control_2
general anesthesia with desflurane at low concentration
Interventions/Control_3
general anesthesia with desflurane at high concentration
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
| 1 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Children undergoing radiofrequency catheter ablation for tachyarrhythmia
Key exclusion criteria
Children with other congenital heart disease than tachyarrhythmia and children undergoing surgery other than radiofrequency catheter ablation
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22 Miyakojima Hondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
ryuokutani0909@ybb.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Ryu Okutani |
Organization
Osaka City General Hospital
Division name
Department of Anesthesiology
Zip code
Address
2-13-22 Miyakojima Hondori, Miyakojima-ku, Osaka
TEL
06-6929-1221
Homepage URL
ryuokutani0909@ybb.ne.jp
Sponsor or person
Institute
Department of Anesthesiology, Osaka City General Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Osaka City General Hospital
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
Address
Tel
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
大阪市立総合医療センター麻酔科
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 09 | Month | 06 | 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
| 2012 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 10 | Day |
Last follow-up date
| 2016 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2016 | Year | 07 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 09 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 09 | Month | 04 | Day |
Last modified on
| 2017 | Year | 09 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010392
