UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000043809
Receipt number R000049980
Scientific Title A Randomized Controlled Trial of the Efficacy of Opioid-Free Anesthesia in Pediatric Cardiac Surgery
Date of disclosure of the study information 2021/04/03
Last modified on 2023/04/05 13:28:26

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 or person

Institute

Okayama University Hospital

Institute

Department

Personal name



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

Enrolling by invitation

Date of protocol fixation

2021 Year 03 Month 20 Day

Date of IRB

2021 Year 09 Month 28 Day

Anticipated trial start date

2021 Year 10 Month 22 Day

Last follow-up date

2027 Year 12 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

2023 Year 04 Month 05 Day



Link to view the page

Value
https://center6.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