UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049191 |
|---|---|
| Receipt number | R000056030 |
| Scientific Title | Evaluation of the Effect of Remimazolam on Intraoperative Motor Evoked Potential Monitoring - Comparison with Propofol |
| Date of disclosure of the study information | 2022/10/11 |
| Last modified on | 2023/10/08 13:42:15 |
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Basic information
Public title
Evaluation of the Effect of Remimazolam on Intraoperative Motor Evoked Potential Monitoring - Comparison with Propofol
Acronym
Evaluation of the Effects of Remimazolam on Intraoperative Motor Evoked Potentials
Scientific Title
Evaluation of the Effect of Remimazolam on Intraoperative Motor Evoked Potential Monitoring - Comparison with Propofol
Scientific Title:Acronym
Evaluation of the Effects of Remimazolam on Intraoperative Motor Evoked Potentials
Region
| Japan |
Condition
Condition
Spine Surgery Patients
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the usefulness of MEP monitoring during general anesthesia with remimazolam.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Is there a difference in the amplitude and latency of MEP and SEP in the nerve travel area unrelated to the surgical site between general anesthesia with propofol and general anesthesia with remimazolam? Compare the difference between control and final MEP values in each case.
Key secondary outcomes
Is there a difference between propofol and remimazolam in the time required from the end of anesthetic administration until neurologic findings can be obtained?
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Among the patients who underwent spinal surgery and were monitored for MEP
(1) ASA-PS1 and 2 patients who are 18 years of age or older
(ii) Patients who have given a full explanation of the study and who have given their free and voluntary written consent based on full understanding.
Key exclusion criteria
(1) Patients with epileptic seizures or history of epilepsy
2) Patients with muscle disease
3) Patients with peripheral neuropathy
(iv) Patients in shock
(5) Patients in coma
(vi) Patients with a history of drug dependence
(g) Patients with hepatic dysfunction
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Kotaro |
| Middle name | |
| Last name | Hamada |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Anesthesiology
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu City
TEL
0936031611
k-hamada@med.uoeh-u.ac.jp
Public contact
Name of contact person
| 1st name | Kotaro |
| Middle name | |
| Last name | Hamada |
Organization
University of Occupational and Environmental Health, Japan
Division name
Department of Anesthesiology
Zip code
807-8555
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu City
TEL
0936031611
Homepage URL
k-hamada@med.uoeh-u.ac.jp
Sponsor or person
Institute
University of Occupational and Environmental Health, Japan
Institute
Department
Personal name
Funding Source
Organization
University of Occupational and Environmental Health, Japan
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
Ethics Committee of Medical Research,University of Occupational and Environmental Health,Japan
Address
1-1 Iseigaoka, Yahatanishi-ku, Kitakyushu City
Tel
0936031611
k-hamada@med.uoeh-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
| 2022 | Year | 10 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 12 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 01 | Month | 04 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 10 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
suspension of research
Management information
Registered date
| 2022 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 10 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056030
| 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 |
