UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052871 |
|---|---|
| Receipt number | R000060336 |
| Scientific Title | Investigation of the degree of concordance between changes in high frequency variable index and the timing of analgesic adjustments by anesthesiologists |
| Date of disclosure of the study information | 2023/11/22 |
| Last modified on | 2024/03/22 10:04:09 |
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Basic information
Public title
Investigation of the degree of concordance between changes in high frequency variable index and the timing of analgesic adjustments by anesthesiologists
Acronym
Investigation of the degree of concordance between changes in high frequency variable index and the timing of analgesic adjustments by anesthesiologists
Scientific Title
Investigation of the degree of concordance between changes in high frequency variable index and the timing of analgesic adjustments by anesthesiologists
Scientific Title:Acronym
Investigation of the degree of concordance between changes in high frequency variable index and the timing of analgesic adjustments by anesthesiologists
Region
| Japan |
Condition
Condition
This is a secondary analysis of data from 48 cases from a previous study (UMIN000048816, study titile: Prediction of postoperative effectiveness of nerve block in video/ robotic -assisted thoracoscopic surgery by using high frequency variability index (HFVI), an index of parasympathetic tone: prospective observational study)
).
Classification by specialty
| Anesthesiology | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to investigate the extent to which changes in HFVI during surgery reflect actual anesthesiologists' behavior of adjusting analgesics. In this study,
1. The concordance rate of changes in HFVI at the time the anesthesiologist acted.
2. Percentage of anesthesiologists who actually acted at the time when a change in HFVI occurred such that it would be acceptable to adjust analgesics.
We approach the relationship between changes in HFVI and anesthesiologist behavior from these two directions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Percentage of significant changes in HFVI during the maintenance phase of anesthesia at the time of remifentanil dosage adjustment.
Key secondary outcomes
During the anesthesia maintenance phase, evaluate the following four points.
1. Percentage of significant change in HFV at the time when fentanyl was administered.
2. Percentage of change in PSi value when analgesics (remifentanil and fentanyl) were adjusted.
3. Percentage of patients who actually received analgesics (remifentanil or fentanyl) at the time when it was considered appropriate to adjust the administration of analgesics based on the change in HFVI.
4. Percentage of patients who actually adjusted analgesics (remifentanil and fentanyl) when changes in PSi values were observed and changes in HFVI indicated that adjustments in analgesic dosing may be warranted.
Base
Study type
Others,meta-analysis etc
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
| 120 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This is a secondary analysis of data from 48 cases from a previous study (UMIN000048816, study titile: Prediction of postoperative effectiveness of nerve block in video/ robotic -assisted thoracoscopic surgery by using high frequency variability index (HFVI), an index of parasympathetic tone: prospective observational study)
Key exclusion criteria
Patients or timings that fall into any of the following categories will be excluded from the study.
1. Timing before the start of surgery or after the end of surgery
2. Patients with a large number of intraoperative HFVI deficiencies
3. Patients for whom analgesic dosage adjustment was not performed during surgery
4. Timing of analgesic adjustment in advance of the upcoming stimulus as prior analgesia
5. Timing of periodic drug administration (e.g., periodic addition of fentanyl to adjust effective site concentration)
6. Timing of possible adjustment of analgesics for postoperative analgesia (e.g., addition of fentanyl at the end of surgery)
7. Timing of possible changes in HFVI levels due to bolus administration of circulatory agonists
By excluding these cases or timings, the investigators identify when the anesthesiologist adjusted analgesics for adequate and/or inadequate analgesia. This task will be performed by three anesthesiologists out of the six principal investigators and research assistants, and the decision will be made with the approval of at least two of them.
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
0245471342
masui@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Keisuke |
| Middle name | |
| Last name | Yoshida |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
9601295
Address
1 Hikarigaoka, Fukushima, Fukushima
TEL
0245471342
Homepage URL
masui@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Ethics Committee of Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Fukushima
Tel
0245471825
fmurec@fmu.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
| 2023 | Year | 11 | Month | 22 | 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
Terminated
Date of protocol fixation
| 2023 | Year | 11 | Month | 22 | Day |
Date of IRB
| 2023 | Year | 11 | Month | 22 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 01 | 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
The targeted data will be collected from December 2023 to December 2024.
The following data will be collected:
* Patient information: age, gender, height, weight, body surface area, comorbidities, preoperative disease, and procedure.
* Identification of the timing of analgesic dosage adjustment on the anesthesia chart (using vital signs on the anesthesia chart and images of the surgical field stored in the electronic medical record as the basis for judgment)
* HFVI that is blinded to the anesthesiologist: changes during surgery, especially within 2 or 10 minutes of analgesic dose adjustment.
* Root monitor information other than HFVI: brain wave monitor (PSi)
* Use of circulatory agonists during analgesic dose adjustment
Supplementation
* The "timing of analgesic dose adjustment" focuses on the timing of continuous remifentanil dosage adjustment of 1 ml/h or more and fentanyl dosage adjustment of 50 mcg or more.
* The timing of dose increase/decrease of a continuously administered circulatory agonist (phenylephrine or noradrenaline) should also be treated as "timing of analgesic dose adjustment" if it is done at a time when analgesia is considered adequate/inadequate.
* A "change in HFVI" is defined as a change of 30 or more in HFVIi (average HFVI over 2 minutes) or a change of 50 or more in HFVIm (average HFVI over 4 minutes) in the range of 2 minutes before the timing of interest. The same definition is used for "when a change in HFVI indicates that it is appropriate to adjust analgesic dosing.
* A "change in PSi value" is defined as a change of 10 or more from the baseline in the range of 5 minutes prior to the timing of interest.
* The threshold value in the definition of "change in HFVI" is subject to change in the course of the research analysis. If the relevant analysis subject deviates significantly from the original assumption of about 50-150 timing, a more appropriate threshold will be considered and reported together with the results.
Management information
Registered date
| 2023 | Year | 11 | Month | 22 | Day |
Last modified on
| 2024 | Year | 03 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060336
