UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057024 |
|---|---|
| Receipt number | R000065146 |
| Scientific Title | Evaluation of the effect of remimazolam on A-delta fiber-selective nociceptive evoked potentials. |
| Date of disclosure of the study information | 2025/02/17 |
| Last modified on | 2025/02/13 23:11:47 |
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Basic information
Public title
Evaluation of the effect of remimazolam on A-delta fiber-selective nociceptive evoked potentials.
Acronym
Evaluation of the effect of remimazolam on A-delta fiber-selective nociceptive evoked potentials.
Scientific Title
Evaluation of the effect of remimazolam on A-delta fiber-selective nociceptive evoked potentials.
Scientific Title:Acronym
Evaluation of the effect of remimazolam on A-delta fiber-selective nociceptive evoked potentials.
Region
| Japan |
Condition
Condition
Patients undergoing general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of remimazolam on evoked potentials by measuring A-delta fiber-selective nociceptive evoked potentials using an intraepidermal stimulating electrode and comparing evoked potential amplitudes before and after remimazolam use.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitude of nociceptive evoked potentials
Key secondary outcomes
Latency of nociceptive evoked potentials, NRS, BIS index, MOAA/S
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Using a simulation model, set the continuous intravenous infusion rate so that the effect site concentration from continuous intravenous remimazolam infusion is (1) 0.2 micro g/ml and (2) 0.5 micro g/ml according to the age, height, and weight of the patient. The induction dose of remimazolam in the package insert should not exceed 12 mg/kg/hour.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(i) Patients 20 years of age or older at the time of obtaining consent
(ii) Patients undergoing general anesthesia with remimazolam
(iii) Patients who have given a full explanation of their participation in this study and who have given written consent based on their own free will.
Key exclusion criteria
(1) Patients with ASA-PS of 3 or higher
(2) Patients undergoing surgery for malignant tumors, and patients for whom the site of electrode application is the surgical site
(3) Patients diagnosed with diabetes, dementia, or epilepsy
(4) Patients with a pacemaker, implantable cardioverter-defibrillator, or deep brain stimulator
(5) Patients with skin lesions or numbness at the electrode site
(6) Patients with communication difficulties (e.g., non-Japanese speakers, patients with mental retardation, patients with consciousness disorders)
(7) Pregnant patients
(8) Patients with allergy to remimazolam or other benzodiazepines
(9) Other patients who are judged by the investigator to be difficult to conduct the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kunihiro |
| Middle name | |
| Last name | Mitsuzawa |
Organization
Shinshu University School of Medicine
Division name
The Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1 Asahi, Matsumoto City, Nagano
TEL
0263-37-2670
mitsukuni@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Kunihiro |
| Middle name | |
| Last name | Mitsuzawa |
Organization
Shinshu University School of Medicine
Division name
The Department of Anesthesiology and Resuscitology
Zip code
390-0807
Address
3-1-1 Asahi, Matsumoto City, Nagano
TEL
09088009282
Homepage URL
mitsukuni@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
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
Shinshu University School of Medicine Ethics Committee for Research in Life Sciences and Medicine
Address
3-1-1 Asahi, Matsumoto City, Nagano
Tel
0263-37-2572
mdrinri@shinshu-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
| 2025 | Year | 02 | Month | 17 | 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
| 2025 | Year | 01 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 02 | Month | 17 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 02 | Month | 13 | Day |
Last modified on
| 2025 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065146
