UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053333 |
|---|---|
| Receipt number | R000060874 |
| Scientific Title | The effect of remimazolam on the amplitude of transcranial electrical motor-evoked potentials in spine surgery: A prospective interventional study |
| Date of disclosure of the study information | 2024/01/12 |
| Last modified on | 2024/01/29 15:38:29 |
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Basic information
Public title
The effect of remimazolam on transcranial electrical motor-evoked potentials
Acronym
The effect of remimazolam on transcranial electrical motor-evoked potentials
Scientific Title
The effect of remimazolam on the amplitude of transcranial electrical motor-evoked potentials in spine surgery: A prospective interventional study
Scientific Title:Acronym
The effect of remimazolam on transcranial electrical motor-evoked potentials in spine surgery: A prospective interventional study
Region
| Japan |
Condition
Condition
Spine and spinal cord surgery
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Remimazolam is a newly introduced ultra-short-acting benzodiazepine. Remimazolam may have a better profile for surgeries that require intraoperative neurophysiological monitoring because early postoperative neurological examinations may be possible after anesthesia with remimazolam by using flumazenil, a benzodiazepine antagonist and because remimazolam has been reported to affect hemodynamic parameters less than does propofol. However, the effect of remimazolam on the motor-evoked potential (MEP) has not been investigated. A preliminary study conducted in our hospital suggested that the amplitude of MEP was not affected by the increment of remimazolam. Based on the results of the preliminary research, this study aims to determine the effects of remimazolam on the amplitude of MEPs.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Probability that the MEP amplitude of the left gastrocnemius muscle decreases by less than 50% after the remimazolam dose is increased from 1 mg/kg/h to 2 mg/kg/h
Key secondary outcomes
･The amplitudes and the onset latency of MEP in each muscle in two different doses of remimazolam
･The amplitudes and the latency of somatosensory evoked potentials (SSEP) in two different doses of remimazolam
･The amplitudes of the evoked electromyograms (M-wave, F-wave, H-reflex) in two different doses of remimazolam
･Plasma concentrations of remimazolam under continuous infusion of remimazolam in two different doses
･Change in MEP amplitude over time
･Stimulus intensity required for supramaximal stimulation
･Number of muscles for which MEP could be recorded in two doses of remimazolam
･The time from termination of remimazolam infusion to neurological exam
･Hemodynamic changes and the dosage of the vasopressors
･Changes in bispectral index values
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
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
General anesthesia is maintained with remimazolam (1 mg/kg/h) and remifentanil. After the tracheal intubation, baseline values of TCE-MEP, SSEP, H-reflex, F-wave, and M-wave are recorded with the patient placed in a prone position. At this timepoint, a blood sample is collected to measure the plasma concentration of remimazolam at 1 mg/kg/h. Next, after a bolus dose of 0.05 - 0.1 mg/kg remimazolam is administered, the dose of remimazolam is increased to 2 mg/kg/h. Ten minutes after the increment, TCE-MEP, SSEP, H-reflex, F-wave, and M-wave are recorded and the blood sample is collected again.
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
1) Adults aged over 18 years old with ASA class 1, 2, or 3
2) Patients who schedule for spine and spinal cord surgery requiring MEP monitoring
3) Patients whose written informed consent is obtained after the comprehensive explanation before enrollment of this study
Key exclusion criteria
1) Patients with muscle weakness equivalent to manual muscle testing level 1 or 2
2) A history of seizure, epilepsy, and intracranial diseases including cerebrovascular diseases
3) A history of neuromuscular diseases including myasthenia gravis
4) Acute angle closure glaucoma
5) A history of peripheral nerve dysfunction
6) Shock state
7) Coma
8) A history of drug addiction
9) Liver dysfunction
10) Pregnant women
11) Patients less than 18 years old
12) Body mass index > 35 or < 14
13) ASA class 4 or 5
14) A history of allergic reaction to any of the drugs used in this study
15) Patients taking benzodiazepines prior to the surgery
16) Patients who are considered to be inappropriate for this study by physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kenta |
| Middle name | |
| Last name | Furutani |
Organization
Niigata University Medical and Dental Hospital
Division name
Anesthesiology
Zip code
9518520
Address
1-754, Asahimachi-dori, Chuo ward Niigata city, Niigata prefecture, Japan
TEL
0252272328
masui@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenta |
| Middle name | |
| Last name | Furutani |
Organization
Niigata University Medical and Dental Hospital
Division name
Anesthesiology
Zip code
9518520
Address
1-754, Asahimachi-dori, Chuo ward Niigata city, Niigata prefecture, Japan
TEL
0252272328
Homepage URL
masui@med.niigata-u.ac.jp
Sponsor or person
Institute
Niigata University
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
Research Ethics Review Committee for Humans
Address
1-757, Asahimachidori, Chuo ward Niigata city, Niigata prefecture, Japan
Tel
025-227-2625
ethics@adm.niigata-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
新潟大学医歯学総合病院
Niigata University Medical and Dental Hospital
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 01 | Month | 12 | 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
Open public recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 12 | Day |
Date of IRB
| 2023 | Year | 07 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2027 | 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
| 2024 | Year | 01 | Month | 12 | Day |
Last modified on
| 2024 | Year | 01 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060874
