UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053710 |
|---|---|
| Receipt number | R000061284 |
| Scientific Title | Investigation of individual differences in respiratory rate and HFVi (High Frequency Variability Index) values as indicators of pain during general anesthesia. |
| Date of disclosure of the study information | 2024/02/26 |
| Last modified on | 2024/02/26 15:07:12 |
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Basic information
Public title
Investigation of individual differences in respiratory rate and HFVi (High Frequency Variability Index) values as indicators of pain during general anesthesia.
Acronym
Investigation of individual differences in respiratory rate and HFVi (High Frequency Variability Index) values as indicators of pain during general anesthesia.
Scientific Title
Investigation of individual differences in respiratory rate and HFVi (High Frequency Variability Index) values as indicators of pain during general anesthesia.
Scientific Title:Acronym
Investigation of individual differences in respiratory rate and HFVi (High Frequency Variability Index) values as indicators of pain during general anesthesia.
Region
| Japan |
Condition
Condition
Fracture surgery cases under general anesthesia management
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to investigate the correlation and individual differences between respiratory frequency and HFVi values as pain indicators during general anesthesia under spontaneous respiration.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory Rate (times/min) HFVi (120 seconds/240 seconds) Fentanyl dosage
Key secondary outcomes
Blood pressure Heart Rate BIS ETCO2 fentanyl blood concentration (predicted value) Postoperative pain (VAS scale)
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
General anesthesia surgery for fractures performed in the operating room of Showa University Yokohama Northern Hospital
Key exclusion criteria
Cases using muscle relaxants and remifentanil
Cases requiring tracheal intubation
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yamamura |
| Middle name | |
| Last name | Aya |
Organization
Showa 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
ayayamamura128@gmail.com
Public contact
Name of contact person
| 1st name | Yamamura |
| Middle name | |
| Last name | Aya |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiolog
Zip code
2248503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
Homepage URL
ayayamamura128@gmail.com
Sponsor or person
Institute
Showa University
Institute
Department
Personal name
Aya Yamamura
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
| 2024 | Year | 02 | Month | 26 | 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
| 2024 | Year | 02 | Month | 26 | Day |
Date of IRB
| 2024 | Year | 02 | Month | 19 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Investigating the relationship between respiratory rate and HFVi value for pain assessment
Management information
Registered date
| 2024 | Year | 02 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000061284
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
