UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042367 |
|---|---|
| Receipt number | R000048362 |
| Scientific Title | Observational study of the effects of remimazolam on MEP in spinal surgery |
| Date of disclosure of the study information | 2020/11/06 |
| Last modified on | 2025/05/17 21:34:29 |
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Basic information
Public title
Observational study of the effects of remimazolam on MEP in spinal surgery
Acronym
Observational study of the effects of remimazolam on MEP in spinal surgery
Scientific Title
Observational study of the effects of remimazolam on MEP in spinal surgery
Scientific Title:Acronym
Observational study of the effects of remimazolam on MEP in spinal surgery
Region
| Japan |
Condition
Condition
Spine surgery
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the association between the rate of false-positive Motor Evoked Potentials and the drugs
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
False positive rate of Motor Evoked Potentials
Key secondary outcomes
Time required for extubation
Duration ofventilation
Length of stay in the intensive care unit
Remifentanil dosage
Fentanyl dosage
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
| 12 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
>General anesthesia with remimazolam
>Spine surgery
>intra operative monitoring of Motor Evoked Potentials
Key exclusion criteria
>declines or withdraw to consent
>impairment of consciousness
>child
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Kawashima |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
431-3192
Address
1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN
TEL
053-435-2738
shingogo@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Kawashima |
Organization
Hamamatsu University School of Medicine
Division name
Department of Anesthesiology and Intensive Care Medicine
Zip code
431-3192
Address
1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN
TEL
053-435-2738
Homepage URL
shingogo@hama-med.ac.jp
Sponsor or person
Institute
Hamamatsu University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethics Committee of Hamamatsu University School of Medicine
Address
1-20-1, handayama, higashi-ku, hamamatsu, shizuoka, JAPAN
Tel
053-435-2680
rinri@hama-med.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 | 11 | Month | 06 | 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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 08 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Interim analysis will be done when 40 cases are registered
Record the association between the results of motor evoked potentials and total remimazolam dosage
Management information
Registered date
| 2020 | Year | 11 | Month | 06 | Day |
Last modified on
| 2025 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048362
