UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056369 |
|---|---|
| Receipt number | R000064405 |
| Scientific Title | Examination of optimal sedation evaluation method of the new general anesthetic remimazolam by analysis of auditory evoked potentials and electroencephalograms |
| Date of disclosure of the study information | 2024/12/05 |
| Last modified on | 2024/12/05 14:34:20 |
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Basic information
Public title
Examination of optimal sedation evaluation method of the new general anesthetic remimazolam by analysis of auditory evoked potentials and electroencephalograms
Acronym
Examination of optimal sedation evaluation method of the new general anesthetic remimazolam by analysis of auditory evoked potentials and electroencephalograms
Scientific Title
Examination of optimal sedation evaluation method of the new general anesthetic remimazolam by analysis of auditory evoked potentials and electroencephalograms
Scientific Title:Acronym
Examination of optimal sedation evaluation method of the new general anesthetic remimazolam by analysis of auditory evoked potentials and electroencephalograms
Region
| Japan |
Condition
Condition
Oral surgery indications
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In this study, we aimed to measure auditory evoked potentials and electroencephalogram parameters BIS, PSI, and SEF at the time of induction of general anesthesia in patients undergoing dental oral surgery under general anesthesia using remimazolam, and to clarify the relationship between each of the indices for evaluating the degree of sedation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Auditory evoked potentials
Key secondary outcomes
Bispectral Index, PSI, SEF, circulatory dynamics (blood pressure, heart rate), autonomic nervous system (LF/HF, HF, LF)
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
| 20 | years-old | <= |
Age-upper limit
| 40 | years-old | >= |
Gender
Female
Key inclusion criteria
40 patients who visited the Department of Oral and Maxillofacial Surgery at Kagoshima University Hospital, were scheduled to undergo dental surgery under general anesthesia, and expressed their intention to participate in this study.
3.1. Eligibility criteria
1. Diagnosis: Indication of oral surgery
2. Disease stage: Cases in which the dentist judged surgery under general anesthesia to be necessary
3. Age and gender: 20-40 years old, male
4. Inpatients
5. Target period: Only on the day of surgery
Key exclusion criteria
3.2. Exclusion criteria
1. Patients with diseases affecting the hearing, electroencephalogram, or autonomic nervous system
2. Patients with allergies to medications
3. Patients taking benzodiazepines
4. Patients who are otherwise deemed inappropriate by a dentist
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kaoru |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Dental Anesthesiology
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
TEL
0992756288
kaorun@dent.kagoshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Kaoru |
| Middle name | |
| Last name | Yamashita |
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
Division name
Department of Dental Anesthesiology
Zip code
890-8544
Address
8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
TEL
099-275-6288
Homepage URL
kaorun@dent.kagoshima-u.ac.jp
Sponsor or person
Institute
Graduate School of Medical and Dental Sciences, Kagoshima University
Institute
Department
Personal name
Funding Source
Organization
Graduate School of Medical and Dental Sciences, Kagoshima University
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
Department of Dental Anesthesiology, Field of Oral and Maxillofacial Rehabilitation, Advanced Therapeutics Course, Graduate School of Medical and Dental Sciences, Kagoshima University
Address
Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima 890-8544, Japan.
Tel
099-275-6624
crmc@m2.kufm.kagoshima-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 | 12 | Month | 05 | 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
| 2023 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2023 | Year | 10 | Month | 04 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 04 | 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
Measure auditory evoked potentials and electroencephalogram parameters BIS, PSI, and SEF during induction of general anesthesia.
Management information
Registered date
| 2024 | Year | 12 | Month | 05 | Day |
Last modified on
| 2024 | Year | 12 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064405
