UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020113 |
|---|---|
| Receipt number | R000023206 |
| Scientific Title | Effects of remifentanil on systemic inflammatory responses in pediatric cardiac surgery |
| Date of disclosure of the study information | 2015/12/10 |
| Last modified on | 2017/12/30 19:10:43 |
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Basic information
Public title
Effects of remifentanil on systemic inflammatory responses in pediatric cardiac surgery
Acronym
Effects of remifentanil on systemic inflammatory responses in pediatric cardiac surgery
Scientific Title
Effects of remifentanil on systemic inflammatory responses in pediatric cardiac surgery
Scientific Title:Acronym
Effects of remifentanil on systemic inflammatory responses in pediatric cardiac surgery
Region
| Japan |
Condition
Condition
congenital heart disease
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effects of remifentanil on systemic inflammatory responses such as cytokines in pediatric cardiac surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Plasma Levels of cytokines after induction of anesthesia,at the end of cardiopulmonary bypass,the end of surgery and 24 hour after surgery
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
infuse remifentanil at 0.2-0.3 mcg/kg/min from after the anesthetic induction to the end of surgery
Interventions/Control_2
do not use remifentanil
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
| 6 | months-old | <= |
Age-upper limit
| 192 | months-old | > |
Gender
Male and Female
Key inclusion criteria
Ideal criteria for early extubation after open heart surgery with cardiopulmonary bypass at Jichi children's medical center Tochigi.
Key exclusion criteria
Palliative surgery with residual cyanosis, severe heart failure that require open sternum or prolonged mechanical ventilation support, and patients with allergic responce to remifentanil or fentanyl.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoji Otsuka |
Organization
Jichi children's medical center Tochigi, Jichi medical university
Division name
Pediatric operating suite and intensive care unit
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL
0285-58-7383
ohtsuka@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoji Otsuka |
Organization
Jichi children's medical center Tochigi, Jichi medical university
Division name
Pediatric operating suite and intensive care unit
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL
0285-58-7383
Homepage URL
ohtsuka@jichi.ac.jp
Sponsor or person
Institute
Jichi medical university
Institute
Department
Personal name
Funding Source
Organization
Anesthesiology and Critical care medicine, Jichi medical university
Organization
Division
Category of Funding Organization
Other
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
自治医科大学とちぎ子ども医療センター（栃木県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 12 | Month | 10 | 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
| 2013 | Year | 08 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 08 | Month | 27 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 12 | Month | 08 | Day |
Last modified on
| 2017 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023206
