UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059787 |
|---|---|
| Receipt number | R000068361 |
| Scientific Title | Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study |
| Date of disclosure of the study information | 2025/11/15 |
| Last modified on | 2025/11/15 07:29:55 |
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Basic information
Public title
Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study
Acronym
Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study
Scientific Title
Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study
Scientific Title:Acronym
Usefulness of the Aperiodic Component for Assessing Sedation Depth During Remimazolam Administration: A Prospective Observational Study
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia in the operation room
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study was to determine whether the aperiodic component of the anesthesia EEG can assess the depth of anesthesia during remimazolam-based general anesthesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The area under the receiver operating characteristic (ROC) curve (AUC) for the aperiodic component to discriminate between the awake and anesthetized states
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
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Administration of remimazolam
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
| 40 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Female
Key inclusion criteria
1. Patients managed by the attending anesthesiologist
2. Female sex
3. Age between 40 and 65 years
4. ASA physical status I or II
Key exclusion criteria
1. Inability to obtain informed consent
2. Presence of central nervous system disorders (cognitive impairment, stroke, epilepsy, brain tumor, or psychiatric disorders)
3. Use of antiepileptic drugs
4. Allergy to benzodiazepines
5. Current use of benzodiazepines
6. Risk of difficult airway, defined as:
Obesity with a BMI greater than 30
Upper lip bite test class 3
Difficult airway anticipated by the attending anesthesiologist
7. Any other condition judged inappropriate for the study by the attending anesthesiologist or the principal investigator
Target sample size
23
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-shi, Fukushima, Japan
TEL
024-547-1111
masui@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 City, Fukushima, JAPAN
TEL
0245471111
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
Fukushima Medical University Research Ethics Committee
Address
1 Hikarigaoka, Fukushima city, Fukushima
Tel
024-547-1825
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
| 2025 | Year | 11 | Month | 15 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 11 | Month | 14 | Day |
Date of IRB
| 2025 | Year | 11 | Month | 14 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 15 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | 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 | 11 | Month | 15 | Day |
Last modified on
| 2025 | Year | 11 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068361
