UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040606 |
|---|---|
| Receipt number | R000046238 |
| Scientific Title | Electroencephalogramic changes during remimazolam general anesthesia: the relationship between estimated effect-site concentrations and the characteristics of electroencephalogramic changes at unconscious and conscious states |
| Date of disclosure of the study information | 2020/06/05 |
| Last modified on | 2024/06/05 10:29:36 |
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Basic information
Public title
Electroencephalogramic changes during remimazolam general anesthesia: the relationship between estimated effect-site concentrations and the characteristics of electroencephalogramic changes at unconscious and conscious states
Acronym
Electroencephalogramic changes during remimazolam general anesthesia
Scientific Title
Electroencephalogramic changes during remimazolam general anesthesia: the relationship between estimated effect-site concentrations and the characteristics of electroencephalogramic changes at unconscious and conscious states
Scientific Title:Acronym
Electroencephalogramic changes during remimazolam general anesthesia
Region
| Japan |
Condition
Condition
Of patients who are undergoing elective breast surgery, participants are included if they have both of the following:
1) American Society of Anesthesiologist (ASA) physical status (PS) classification 1 or 2
2) Capability of providing written consent before participation to this study
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
In the course of induction and maintenance of general anesthesia using remimazolam, frontal electroencephalograms (EEGs) during induction (from the start of remimazolam administration to loss of consciousness), maintenance , and emergence (from the end of remimazolam administration to recovery of consciousness) phases will be analyzed in order to investigate the relationship between estimated effect-site remimazolam concentrations and the EEG changes.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
The relationship between estimated effect-site remimazolam concentrations, and frontal EEG changes during general anesthetic induction, maintenance , and emergence phases, respectively.
Key secondary outcomes
The relationship between estimated effect-site remimazolam concentrations, and Patient State Index (PSI) during induction , maintenance , and emergence phases, respectively. The trend in EEG frequency change depending on age. The relationship between age and the time from the end of remimazolam administration to recovery of consciousness.
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
| Not applicable |
Gender
Female
Key inclusion criteria
Of patients who are undergoing elective breast surgery, participants are included if they have both of the following:
1) American Society of Anesthesiologist (ASA) physical status (PS) classification 1 or 2
2) Capability of providing written consent before participation to this study
Key exclusion criteria
Participants are excluded if they have any of the following:
1) Contraindications listed on the package insert of remimazolam (hypersensitivity to any of the components of remimazolam, acute closed angle glaucoma, myasthenia gravis, shock, coma, or acute alcoholic poisoning accompanying suppressed vital signs)
2) Contraindication to benzodiazepine
3) History of long-term administration of benzodiazepine
4) Contraindication to fentanyl, remifentanyl, or rocuronium
5) Severe liver dysfunction, renal dysfunction, or heart disease that may affect the safety assessment of remimazolam
6) ASA PS>=3
7) Others that the investigators consider to be inappropriate for a participant of the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Masui |
Organization
Facility of Medicine, Showa University
Division name
Department of Anesthesiology
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa, Tokyo
TEL
03-3784-8575
kmasui@med.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Maiko |
| Middle name | |
| Last name | Hosokawa |
Organization
Facility of Medicine, Showa University
Division name
Department of Anesthesiology
Zip code
142-8666
Address
1-5-8 Hatanodai, Shinagawa, Tokyo
TEL
03-3784-8575
Homepage URL
maikohskw@med.showa-u.ac.jp
Sponsor or person
Institute
Showa University
Department of Anesthesiology
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
The Human Research Committee at Showa University Facility of Medicine
Address
1-5-8 Hatanodai, Shinagawa, Tokyo
Tel
03-3784-8129
m-rinri@ofc.showa-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
昭和大学病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 06 | 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
40
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
due to delay of data analysis
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 02 | Month | 25 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 14 | Day |
Anticipated trial start date
| 2020 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 06 | Month | 01 | Day |
Last modified on
| 2024 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046238
