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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000042367
Receipt No. 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 2021/05/08

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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
Email 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
Email shingogo@hama-med.ac.jp

Sponsor
Institute Hamamatsu University School of Medicine
Institute
Department

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
Email 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 Open public recruiting
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
2022 Year 03 Month 31 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
2021 Year 05 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048362

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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