UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052691 |
|---|---|
| Receipt number | R000060127 |
| Scientific Title | Evaluation of F wave characteristics under remimazolam anesthesia in spine surgery. |
| Date of disclosure of the study information | 2024/01/01 |
| Last modified on | 2025/11/04 14:50:10 |
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Basic information
Public title
Investigation of F waves under remimazolam anesthesia in spine surgery.
Acronym
F waves under remimazolam anesthesia
Scientific Title
Evaluation of F wave characteristics under remimazolam anesthesia in spine surgery.
Scientific Title:Acronym
Evaluation of F wave characteristics under remimazolam anesthesia
Region
| Japan |
Condition
Condition
Spine and spinal cord disease
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the F wave using our original anesthesia method in which the remimazolam anesthesia depth is kept constant.
Basic objectives2
Others
Basic objectives -Others
Evaluation of anesthetic fade
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
F wave parameter
Key secondary outcomes
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients scheduled for spinal cord surgery using MEP monitoring at our hospital
Key exclusion criteria
1) Patients scheduled for spinal cord surgery at the cervical level
2) Patients with cardiac pacemakers or implantable cardioverter defibrillators
3) Patients who regularly use psychotropic drugs such as benzodiazepines
4) Patients with a history of epilepsy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Sachiko |
| Middle name | |
| Last name | Kawasaki |
Organization
Nara Medical University
Division name
Department of Orthopaedic Surgery
Zip code
634-8522
Address
840 Shijyocho, Kashihara, Nara
TEL
0744-22-3051
sachi-kawa@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Sachiko |
| Middle name | |
| Last name | Kawasaki |
Organization
Nara Medical University
Division name
Department of Orthopaedic Surgery
Zip code
634-8522
Address
840 Shijyocho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
sachi-kawa@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara medical University
Address
840 Shijyocho, Kashihara, Nara
Tel
0744-22-3051
sachi-kawa@naramed-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
| 2024 | Year | 01 | 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
34
Results
Four cases (16%) had preoperative motor paralysis of MMT 3 or lower. The median frequency of F-wave appearance was 16 times (range 8-16) at baseline, 16 times (range 0-16) at 3 hours, and 16 times (range 0-16) at completion. In 3 of the 4 cases with preoperative motor paralysis, F-waves were detected 16 times from baseline to completion.
Results date posted
| 2025 | Year | 11 | Month | 04 | Day |
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
| 2023 | Year | 11 | Month | 05 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
intraoperative monitoring
Management information
Registered date
| 2023 | Year | 11 | Month | 03 | Day |
Last modified on
| 2025 | Year | 11 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060127
