UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058926 |
|---|---|
| Receipt number | R000067363 |
| Scientific Title | A prospective observational study on the association between emergence agitation after pediatric general anesthesia and the High Frequency Variability Index (HFVI) |
| Date of disclosure of the study information | 2025/09/01 |
| Last modified on | 2025/08/26 21:14:41 |
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Basic information
Public title
Emergence agitation after pediatric general anesthesia and its relationship with HFVI
Acronym
Emergence agitation after pediatric general anesthesia and its relationship with HFVI
Scientific Title
A prospective observational study on the association between emergence agitation after pediatric general anesthesia and the High Frequency Variability Index (HFVI)
Scientific Title:Acronym
A prospective observational study on the association between emergence agitation after pediatric general anesthesia and the High Frequency Variability Index (HFVI)
Region
| Japan |
Condition
Condition
Pediatric patients aged 2 to 10 years, classified as ASA physical status I or II, scheduled to undergo inguinal hernia repair or tonsillectomy under general anesthesia
Classification by specialty
| Surgery in general | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to clarify whether the High Frequency Variability Index (HFVI) is associated with the development of emergence delirium (ED) in pediatric patients. HFVI is a noninvasive indicator of parasympathetic nervous activity, and its use may enhance the prediction of ED risk and the possibility of preventive interventions. Establishing a predictive marker for ED is expected to contribute to improving the quality and safety of pediatric anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Measurement of HFVI at three time points (preoperative, intraoperative, and immediately before emergence)
Assessment of PAED score after emergence
Key secondary outcomes
Demographic and procedural characteristics: age, sex, body weight, and type of surgery (inguinal hernia repair vs. tonsillectomy)
Anesthesia duration, surgical duration, and emergence time
Vital signs: heart rate, blood pressure, and SpO2
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 2 | years-old | <= |
Age-upper limit
| 10 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Pediatric patients aged 2 to 10 years, classified as ASA physical status I or II, scheduled to undergo inguinal hernia repair or tonsillectomy under general anesthesia at Showa University Yokohama North Hospital
Key exclusion criteria
Patients with a history of cardiac, respiratory, or neurological disorders that may affect HFVI
Patients for whom assessment of the PAED score is difficult, such as those with developmental delay
Patients with a previous history of emergence-related problems under general anesthesia
Patients whose legal guardians are unable to provide written informed consent
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshida |
| Middle name | |
| Last name | AI |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
aiteruya0217@gmail.com
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Yoshida |
Organization
Showa Medical University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
2248503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-9497332
Homepage URL
aiteruya0217@gmail.com
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Ai Yoshida
Funding Source
Organization
Showa University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-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
| 2025 | Year | 09 | Month | 01 | 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
| 2025 | Year | 08 | Month | 29 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 29 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
This study aims to investigate whether the High Frequency Variability Index (HFVI) is associated with emergence delirium (ED) in pediatric patients. HFVI is a noninvasive measure of parasympathetic activity and may help predict ED risk and guide preventive interventions.
Management information
Registered date
| 2025 | Year | 08 | Month | 29 | Day |
Last modified on
| 2025 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067363
