UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Efficacy of Opioid-Free Anesthesia in Pediatric Cardiac Surgery
Acronym	A Study on the Efficacy of Opioid-Free Anesthesia in Pediatric Cardiac Surgery
Scientific Title	A Randomized Controlled Trial of the Efficacy of Opioid-Free Anesthesia in Pediatric Cardiac Surgery
Scientific Title:Acronym	A Randomized Controlled Trial of the Efficacy of Opioid-Free Anesthesia in Pediatric Cardiac Surgery
Region	Japan

Condition
Condition	Atrial septal defect and ventricular septal defect
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To determine whether opioid-free anesthesia with pain control by intercostal nerve block accelerates weaning from ventilation compared with anesthesia with pain control by opioids in pediatric cardiac surgery.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase

Assessment
Primary outcomes	Success rate of extubation in the operating room
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	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Fentanyl 3mcg/kg is administered at the time of anesthesia induction, and ultrasound-guided intercostal nerve blocks (3-5 mL of 0.2-0.375% ropivacaine per intercostal space) are performed in the planned open intercostal space and one intercostal space above and below it for a total of three intercostal spaces before the procedure.
Interventions/Control_2	Fentanyl 3 mcg/kg is administered at the time of anesthesia induction, and fentanyl 10 mcg/kg is at the start of surgery.
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	12 years-old >
Gender	Male and Female
Key inclusion criteria	1) Patients undergoing radical minimally invasive cardiac surgery with lateral chest opening for atrial septal defect or ventricular septal defect 2) Patients under 12 years of age at the time of obtaining consent 3) Patients with written consent from a surrogate
Key exclusion criteria	1) Patients taking antithrombotic or anticoagulant medication 2) Patients with suspected coagulation disorders based on preoperative blood coagulation tests 3) Patients undergoing emergency surgery
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Tomoyuki Middle name Last name Kanazawa
Organization	Okayama University Hospital
Division name	Department of Anesthesiology and Resuscitology
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7778
Email	tyskanazawa@gmail.com

Public contact
Name of contact person	1st name Tatsuhiko Middle name Last name Shimizu
Organization	Okayama University Hospital
Division name	Department of Anesthesiology and Resuscitology
Zip code	700-8558
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
TEL	086-235-7778
Homepage URL
Email	t.shimizu.8479@gmail.com

Sponsor
Institute	Okayama University Hospital
Institute
Department

Funding Source
Organization	None
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	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences and Okayama University Hospital, Ethics Committee
Address	2-5-1, Shikata-cho, Kita-ku, Okayama, Japan
Tel	086-235-6938
Email	mae6605@adm.okayama-u.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

Other administrative information
Date of disclosure of the study information	2021 Year 04 Month 03 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	Preinitiation
Date of protocol fixation	2021 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date	2021 Year 06 Month 22 Day
Last follow-up date	2027 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 04 Month 01 Day
Last modified on	2021 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049980

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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