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 |
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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
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
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
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
