UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of remifentanil on systemic inflammatory responses in pediatric cardiac surgery
Title of the study (Brief title)	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	Yoji Otsuka
Organization	Jichi children's medical center Tochigi, Jichi medical university
Division name	Pediatric operating suite and intensive care unit
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL	0285-58-7383
Email	ohtsuka@jichi.ac.jp

Public contact
Name of contact person	Yoji Otsuka
Organization	Jichi children's medical center Tochigi, Jichi medical university
Division name	Pediatric operating suite and intensive care unit
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL	0285-58-7383
Homepage URL
Email	ohtsuka@jichi.ac.jp

Sponsor
Institute	Jichi medical university
Institute
Department

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)

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

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2013 Year 08 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023206