UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063089 |
|---|---|
| Receipt number | R000072199 |
| Scientific Title | Agreement Between SedLine-Derived BIS Calculated From SedLine EEG and Native BIS Monitor Values in Patients Undergoing General Anesthesia: A Prospective Observational Study |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/29 06:41:56 |
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Basic information
Public title
Agreement Between SedLine-Derived BIS Calculated From SedLine EEG
and Native BIS Monitor Values in Patients Undergoing General Anesthesia:
A Prospective Observational Study
Acronym
Agreement Between SedLine-Derived BIS Calculated From SedLine EEG
and Native BIS Monitor Values in Patients Undergoing General Anesthesia:
A Prospective Observational Study
Scientific Title
Agreement Between SedLine-Derived BIS Calculated From SedLine EEG
and Native BIS Monitor Values in Patients Undergoing General Anesthesia:
A Prospective Observational Study
Scientific Title:Acronym
Agreement Between SedLine-Derived BIS Calculated From SedLine EEG
and Native BIS Monitor Values in Patients Undergoing General Anesthesia:
A Prospective Observational Study
Region
| Japan |
Condition
Condition
Adult patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The primary objective is to evaluate agreement between SedLine-derived BIS calculated from SedLine raw EEG and native BIS obtained from a simultaneously applied BIS monitor in patients undergoing general anesthesia, using repeated-measures Bland-Altman analysis.
Basic objectives2
Others
Basic objectives -Others
Secondary objectives are to exploratorily evaluate Lin's CCC between the two measures, mean absolute error (MAE), root mean squared error (RMSE), agreement stratified by anesthetic phase, the proportion of 30-second periods in which the BIS values differ by 10 units or more, agreement in clinically relevant BIS categories, trending performance using four-quadrant and polar plot analyses, and the relationships of PSi with native BIS and SedLine-derived BIS.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Agreement between SedLine-derived BIS (index test) and native BIS (reference test), assessed using repeated-measures Bland-Altman analysis. The prespecified criterion for acceptable agreement is that the lower bound of the 95% confidence interval for the lower limit of agreement is not less than -17 BIS units and the upper bound of the 95% confidence interval for the upper limit of agreement is not greater than +17 BIS units.
Key secondary outcomes
Lin's concordance correlation coefficient (Lin's CCC) and its 95% confidence interval; mean absolute error (MAE); root mean squared error (RMSE); agreement in clinically relevant BIS categories; the proportion of 30-second periods in which the BIS values differ by 10 units or more; trending performance assessed using four-quadrant and polar plot analyses; development of a correction equation to estimate native BIS from SedLine-derived BIS; analyses stratified by sex and anesthetic phase; and the relationships of PSi with native BIS and SedLine-derived BIS.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years or older at the time informed consent was obtained.
2. American Society of Anesthesiologists Physical Status (ASA-PS) class I or II.
3. Scheduled to undergo surgery under general anesthesia at Fukushima Medical University Hospital.
4. pEEG monitoring with SedLine is planned intraoperatively, or the attending anesthesiologist determines that placement of SedLine is clinically acceptable.
5. Surgery is performed in the supine or lithotomy position.
6. Scheduled surgery is an orthopedic or gynecologic procedure.
7. Written informed consent for study participation is obtained from the participant.
Key exclusion criteria
1. Central nervous system disease, including cognitive impairment, stroke, epilepsy, brain tumor, or psychiatric disease.
2. Use of medications with substantial effects on the central nervous system, including antiepileptic drugs, benzodiazepines, or hypnotics.
3. Known or suspected risk of contact dermatitis or allergic symptoms from application of the study devices.
4. High risk associated with anesthetic management.
5. Data cannot be collected because of limited device availability.
Target sample size
65
Research contact person
Name of lead principal investigator
| 1st name | Takayuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Fukushima, Japan
TEL
024-547-1111
taka-h@fmu.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Hasegawa |
Organization
Fukushima Medical University
Division name
Department of Anesthesiology
Zip code
960-1295
Address
1 Hikarigaoka, Fukushima, Fukushima, Japan
TEL
024-547-1111
Homepage URL
taka-h@fmu.ac.jp
Sponsor or person
Institute
Fukushima Medical University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science (JSPS)
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee of Fukushima Medical University
Address
1 Hikarigaoka, Fukushima, Fukushima 960-1295, Japan
Tel
024-547-1825
rs@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
福島県立医科大学附属病院(福島県)
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 29 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 19 | Day |
Last follow-up date
| 2028 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
none
Management information
Registered date
| 2026 | Year | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072199
