UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058212 |
|---|---|
| Receipt number | R000066551 |
| Scientific Title | Correlation between Patient State Index and Bispectral Index during General Anesthesia with Remimazolam |
| Date of disclosure of the study information | 2025/06/18 |
| Last modified on | 2025/06/18 16:55:12 |
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Basic information
Public title
Correlation between Patient State Index and Bispectral Index during General Anesthesia with Remimazolam
Acronym
Correlation between Patient State Index and Bispectral Index during General Anesthesia with Remimazolam
Scientific Title
Correlation between Patient State Index and Bispectral Index during General Anesthesia with Remimazolam
Scientific Title:Acronym
Correlation between Patient State Index and Bispectral Index during General Anesthesia with Remimazolam
Region
| Japan |
Condition
Condition
Diseases requiring general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Correlation between Patient State Index and Bispectral Index during General Anesthesia with Remimazolam
Basic objectives2
Others
Basic objectives -Others
Correlation between Patient State Index and Bispectral Index during General Anesthesia with Remimazolam
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between Patient State Index and Bispectral Index during General Anesthesia with Remimazolam
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Patient State Index and Bispectral Index are simultaneously applied and their values are observed.
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients aged 20 years or older undergoing general anesthesia with remimazolam.
Key exclusion criteria
Patients who do not provide informed consent, patients undergoing emergency surgery, and those deemed inappropriate for the study by the investigators.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yuichi |
| Middle name | |
| Last name | Yaguchi |
Organization
Hitachi General Hospital
Division name
Anesthesiogogy
Zip code
3170077
Address
2-1-1Jyounancho Hitachi Ibaraki Japan
TEL
0294-23-1111
takuya.shiraishi.fw@hitachi.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Shiraishi |
Organization
Hitachi General Hospital
Division name
Anesthesiology
Zip code
3170077
Address
2-1-1Jyounancho Hitachi Ibaraki Japan
TEL
09025579046
Homepage URL
tshiraishi.1217@gmail.com
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
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
HItachi General Hospital
Address
2-1-1Jyounancho Hitachi Ibaraki Japan
Tel
0294231111
takuya.shiraishi.fw@hitachi.com
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 | 06 | Month | 18 | 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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 06 | Month | 18 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 18 | Day |
Last modified on
| 2025 | Year | 06 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066551
