UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040328 |
|---|---|
| Receipt number | R000046016 |
| Scientific Title | Depth of anesthesia and electroencephalogram |
| Date of disclosure of the study information | 2020/05/15 |
| Last modified on | 2022/05/10 09:55:43 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Depth of anesthesia and electroencephalogram
Acronym
Depth of anesthesia
Scientific Title
Depth of anesthesia and electroencephalogram
Scientific Title:Acronym
Depth of anesthesia and electroencephalogram
Region
| Japan |
Condition
Condition
Fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Relationships between depth of anesthesia and EEG
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
bispectral index
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Concentration of Anesthetics: 1 MAC
Interventions/Control_2
Concentration of Anesthetics: 1.5 MAC
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
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Subjects undergoing orthopedic surgery for fracture
Key exclusion criteria
psychiatry disease
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yutaka |
| Middle name | |
| Last name | oda |
Organization
Osaka City Juso Hospital
Division name
anesthesiology
Zip code
532-0034
Address
Nonaka-kita, Yodogawa-ku, Osaka
TEL
06-6150-8000
yutakaodayutaka@gmail.com
Public contact
Name of contact person
| 1st name | Yutaka |
| Middle name | |
| Last name | Oda |
Organization
Osaka City Juso Hospital
Division name
Anesthesioogy
Zip code
532
Address
2-12-17
TEL
0661508000
Homepage URL
yutakaodayutaka@gmail.com
Sponsor or person
Institute
Osaka City Juso Hospital
Institute
Department
Personal name
Funding Source
Organization
Osaka City Juso 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
Osaka City Juso Hospital
Address
Nonaka-kita, Yodogawa-ku, Osaka
Tel
0661508000
yutakaodayutaka@gmail.com
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 | 05 | Month | 15 | 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 | 04 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 04 | Month | 30 | Day |
Anticipated trial start date
| 2020 | Year | 05 | Month | 20 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 05 | Month | 08 | Day |
Last modified on
| 2022 | Year | 05 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046016
