UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042085 |
|---|---|
| Receipt number | R000048029 |
| Scientific Title | The examination of sedation depth of remimazolam in general anesthesia: Pilot study |
| Date of disclosure of the study information | 2020/10/20 |
| Last modified on | 2022/04/14 10:01:18 |
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Basic information
Public title
The examination of sedation depth of remimazolam in general anesthesia: Pilot study
Acronym
The examination of sedation depth of remimazolam in general anesthesia: Pilot study
Scientific Title
The examination of sedation depth of remimazolam in general anesthesia: Pilot study
Scientific Title:Acronym
The examination of sedation depth of remimazolam in general anesthesia: Pilot study
Region
| Japan |
Condition
Condition
the patients of breast tumor
Classification by specialty
| Breast surgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To examine the objective evaluation of the depth of anesthesia of remimazolam, using by portable infrared pupilometer and BIS monitor.
Basic objectives2
Others
Basic objectives -Others
An objective assessment of the depth of anesthesia with remimazolam will be examined in terms of the degree of sympathetic excitation.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship between BIS Values and Pupil Response
Key secondary outcomes
Relationship between Intraoperative EEG Monitored Values and Pupil Response
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
Patients undergoing breast surgery under general anesthesia.
Key exclusion criteria
Patients who are deemed by the investigator to be unsuitable as research subjects
(Underage, insufficient data.)
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | kazuhiro |
| Middle name | |
| Last name | shirozu |
Organization
kyushu university hospital
Division name
anesthesia
Zip code
812-8582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5714
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Public contact
Name of contact person
| 1st name | kazuhiro |
| Middle name | |
| Last name | shirozu |
Organization
kyushu university hospital
Division name
anesthesia
Zip code
812-8582
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
TEL
092-642-5714
Homepage URL
shirozu.kazuhiro.334@m.kyushu-u.ac.jp
Sponsor or person
Institute
kyushu university hospital
Institute
Department
Personal name
Funding Source
Organization
kyushu university hospital
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
kyushu university hospital
Address
Maidashi 3-1-1, Higashi-ku, Fukuoka
Tel
092-642-6254
ijkseimei@jimu.kyushu-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
| 2020 | Year | 10 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
40
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 | 10 | Month | 05 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 05 | Day |
Anticipated trial start date
| 2020 | Year | 10 | Month | 29 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 03 | Month | 31 | Day |
Other
Other related information
prospective observational study
Management information
Registered date
| 2020 | Year | 10 | Month | 12 | Day |
Last modified on
| 2022 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048029
