UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036968 |
|---|---|
| Receipt number | R000041339 |
| Scientific Title | A prospective single-center observational study of intraoperative causes of decreased motor evoked potential in surgery for adolescent scoliosis-especially relationship with bispectral index |
| Date of disclosure of the study information | 2019/07/01 |
| Last modified on | 2023/01/04 10:22:52 |
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Basic information
Public title
A prospective single-center observational study of intraoperative causes of decreased motor evoked potential in surgery for adolescent scoliosis-especially relationship with bispectral index
Acronym
Intraoperative causes of decreased motor evoked potential in surgery for adolescent scoliosis
Scientific Title
A prospective single-center observational study of intraoperative causes of decreased motor evoked potential in surgery for adolescent scoliosis-especially relationship with bispectral index
Scientific Title:Acronym
Intraoperative causes of decreased motor evoked potential in surgery for adolescent scoliosis
Region
| Japan |
Condition
Condition
adolescent scoliosis
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To review the relationship between motor evoked potential amplitude changes and bispectral index
Basic objectives2
Others
Basic objectives -Others
To review the relationship between motor evoked potential amplitude changes and intraoperative factors
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The relationship between motor evoked potential amplitude changes and bispectral index
Key secondary outcomes
The relationship between motor evoked potential amplitude changes and intraoperative factors
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
| 10 | years-old | <= |
Age-upper limit
| 19 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Patients who will have surgery for scoliosis
Key exclusion criteria
1. Patients with above ASA3
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Morimoto |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
060-8648
Address
N14 W5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
morim2@med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takayuki |
| Middle name | |
| Last name | Toki |
Organization
Hokkaido University Hospital
Division name
Anesthesiology
Zip code
060-8648
Address
N14 W5, Kita-ku, Sapporo, Hokkaido
TEL
011-716-1161
Homepage URL
tokihoku0112@frontier.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Hokkaido University Hospital
Anesthesiology
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
Hokkaido University Hospital
Address
N14 W5, Kita-ku, Sapporo, Hokkaido
Tel
011-716-1161
crjimu@huhp.hokudai.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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 07 | Month | 01 | 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
50
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
| 2019 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 03 | Day |
Anticipated trial start date
| 2019 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Study period:until 2022.6.30
Patients scheduled to have scoliosis surgery in the Hokkaido University Hospital
anticipated numbers 50
Observational items: Background, laboratory data, vital signs, motor-evoked potential, bispectral-index
Management information
Registered date
| 2019 | Year | 06 | Month | 05 | Day |
Last modified on
| 2023 | Year | 01 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041339
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
