UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021145 |
|---|---|
| Receipt number | R000024305 |
| Scientific Title | Pharmacokinetics of Rocuronium during pediatric cardiovascular surgery |
| Date of disclosure of the study information | 2016/02/22 |
| Last modified on | 2016/02/26 15:16:10 |
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Basic information
Public title
Pharmacokinetics of Rocuronium during pediatric cardiovascular surgery
Acronym
Pharmacokinetics of Rocuronium during pediatric cardiovascular surgery
Scientific Title
Pharmacokinetics of Rocuronium during pediatric cardiovascular surgery
Scientific Title:Acronym
Pharmacokinetics of Rocuronium during pediatric cardiovascular surgery
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the pharmacokinetics of rocuronium in cyanotic and acyanotic patients during pediatric cardiac surgery using cardiopulmonary bypass.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The pharmacokinetics of rocuronium in cyanotic and acyanotic patients during pediatric cardiac surgery using cardiopulmonary bypass.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Cyanotic and acyanotic children weighing 5 to 10 kg scheduled for elective congenital cardiac surgery using cardiopulmonary bypass.
Key exclusion criteria
Patients with comorbidities including neuromuscular abnormality, liver and renal dysfunction.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Nakayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5633
na-yoshi@koto.kpu-m.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshinobu Nakayama |
Organization
Kyoto Prefectural University of Medicine
Division name
Department of Anesthesiology
Zip code
Address
465 Kajii-cho, Kamigyo-ku, Kyoto, Japan
TEL
075-251-5633
Homepage URL
na-yoshi@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Kyoto Prefectural University 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
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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 02 | Month | 22 | 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
Open public recruiting
Date of protocol fixation
| 2016 | Year | 02 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 02 | Month | 22 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study.
The patients, who have operations of congenital heart disease from Feb. 22th. 2016 in our hospital and meet the inclusion criteria, will be enrolled in the study.
We will measure serum rocuronium concentration in several points during operation.(TOF ratio, etc.)
Management information
Registered date
| 2016 | Year | 02 | Month | 22 | Day |
Last modified on
| 2016 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024305
