UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041782 |
|---|---|
| Receipt number | R000047689 |
| Scientific Title | The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study |
| Date of disclosure of the study information | 2020/09/14 |
| Last modified on | 2021/09/30 03:20:07 |
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Basic information
Public title
The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study
Acronym
The relationship between a depth of anesthesia and administration of Remimazolam
Scientific Title
The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study
Scientific Title:Acronym
The relationship between a depth of anesthesia using an anesthesia electroencephalograph and administration of Remimazolam: the prospective observational study
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to verify the relationship between a depth of anesthesia and administration of Remimazolam
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The time of loss of consciousness
Key secondary outcomes
EEG changes by an administration of Remimazolam
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA1-2
elective surgery
Key exclusion criteria
weight<70%, >130%
disease or injury affecting the central nervous system
recent use of psychoactive or analgesic medication
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Akihiro |
| Middle name | |
| Last name | Kanaya |
Organization
Sendai Medical Center
Division name
The department of Anesthesiology
Zip code
983-8520
Address
2-11-12, Myagino, Miyagino-ku, Sendai, Japan
TEL
022-293-1111
canal_village0207@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Akihiro |
| Middle name | |
| Last name | Kanaya |
Organization
Sendai Medical Center
Division name
The department of Anesthesiology
Zip code
983-8520
Address
2-11-12, Myagino, Miyagino-ku, Sendai, Japan
TEL
022-293-1111
Homepage URL
canal_village0207@yahoo.co.jp
Sponsor or person
Institute
Sendai Medical center
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethical Review Board of Sendai Medical Center
Address
2-11-12, Myagino, Miyagino-ku, Sendai, Japan
Tel
022-293-1111
113-kanri02@mail.hosp.go.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
| 2020 | Year | 09 | Month | 14 | 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
Completed
Date of protocol fixation
| 2020 | Year | 09 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 14 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Observational study
Management information
Registered date
| 2020 | Year | 09 | Month | 14 | Day |
Last modified on
| 2021 | Year | 09 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047689
