UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058053 |
|---|---|
| Receipt number | R000066217 |
| Scientific Title | Intraoperative changes in HFVi values during pediatric laparoscopic inguinal hernia repair: a pilot observational study |
| Date of disclosure of the study information | 2025/06/06 |
| Last modified on | 2025/06/02 16:37:26 |
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Basic information
Public title
Intraoperative changes in HFVi values during pediatric laparoscopic inguinal hernia repair: a pilot observational study
Acronym
Intraoperative changes in HFVi values during pediatric laparoscopic inguinal hernia repair: a pilot observational study
Scientific Title
Intraoperative changes in HFVi values during pediatric laparoscopic inguinal hernia repair: a pilot observational study
Scientific Title:Acronym
Intraoperative changes in HFVi values during pediatric laparoscopic inguinal hernia repair: a pilot observational study
Region
| Japan |
Condition
Condition
pediatric inguinal hernia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will investigate how analgesic management using conventional anesthesia methods during pediatric inguinal hernia repair is reflected in HFVI values, and to compare the distribution of HFVI values with that observed in adult laparoscopic surgery.
Basic objectives2
Others
Basic objectives -Others
In recent years, nociception monitors devices that objectively display the balance between noxious stimuli and analgesic administration-have been developed. This study aims to investigate how analgesic management using conventional anesthesia methods during pediatric inguinal hernia repair is reflected in HFVI values.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Distribution of HFVI values during surgery (each range: 50, 50-70, and 70)
Key secondary outcomes
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
| 13 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1)Age between 2 and 13 years old (inclusive).
2)ASA Physical Status Classification I or II.
3)Written informed consent obtained from a legally authorized representative.
Key exclusion criteria
1)Patients scheduled for emergency surgery on the day of the operation.
2)Presence of lacerations or edema in the orbital or periorbital area.
3)Patients currently receiving beta-blockers (oral or transdermal)
4)Patients currently receiving oral corticosteroids.
5)Patients with a pacemaker.
6)Patients who have undergone heart transplantation.
7)Patients receiving medications that affect the sinoatrial node (e.g., atropine, anticholinergics).
8)Patients deemed inappropriate for inclusion by the principal or sub-investigator for safety or data integrity reasons.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | YUKA |
| Middle name | |
| Last name | SASAKI |
Organization
Nara Medical University Hospital
Division name
Anesthesiology
Zip code
634-8522
Address
840 Shijo-cho Kashihara, Nara
TEL
0744223051
yukaa0810@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | YUKA |
| Middle name | |
| Last name | SASAKI |
Organization
Nara Medical University Hospital
Division name
Anesthesiology
Zip code
6348522
Address
840 Shijo-cho Kashihara, Nara
TEL
0744223051
Homepage URL
yukaa0810@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Yuka Sasaki
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
Nara Medical University Hospital
Address
840 Shijo-cho Kashihara, Nara
Tel
0744223051
yukaa0810@naramed-u.ac.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
3999
Org. issuing International ID_1
Nara Medical University Hospital
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 | 06 | Month | 06 | 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 | 03 | Month | 19 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 06 | 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
Noninvasive monitoring of High Frequency Variability Index (HFVI) and pupil diameter during laparoscopic inguinal hernia repair. (Anesthesia and drug administration will follow usual practice, with no interventions based on monitoring results.)
Management information
Registered date
| 2025 | Year | 06 | Month | 02 | Day |
Last modified on
| 2025 | Year | 06 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066217
