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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Preinitiation |
Unique ID issued by UMIN | UMIN000040606 |
Receipt No. | 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 | 2020/06/01 |
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
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Acronym | Electroencephalogramic changes during remimazolam general anesthesia
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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
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Scientific Title:Acronym | Electroencephalogramic changes during remimazolam general anesthesia
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Region |
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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 |
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Classification by specialty |
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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 (from the beginning of operations to 10 minutes after), 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.
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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.
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Key secondary outcomes | The relationship between estimated effect-site remimazolam concentrations, and Patient State Index (PSI) and Bispectral Index (BIS) 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 | |
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Eligibility | ||||
Age-lower limit |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
Institute | Showa University
Department of Anesthesiology |
Institute | |
Department |
Funding Source | |
Organization | None |
Organization | |
Division | |
Category of Funding Organization | Other |
Nationality of Funding Organization |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Unpublished |
Result | |
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Baseline Characteristics | |
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IPD sharing Plan description |
Progress | |||||||
Recruitment status | Preinitiation | ||||||
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Other | |
Other related information | None |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046238 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |