UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042484 |
|---|---|
| Receipt number | R000048477 |
| Scientific Title | The effect of remimazolam on sensory evoked potentials |
| Date of disclosure of the study information | 2020/11/17 |
| Last modified on | 2021/07/30 10:27:26 |
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Basic information
Public title
The effect of remimazolam on sensory evoked potentials
Acronym
The effect of remimazolam on sensory evoked potentials
Scientific Title
The effect of remimazolam on sensory evoked potentials
Scientific Title:Acronym
The effect of remimazolam on sensory evoked potentials
Region
| Japan |
Condition
Condition
Patients undergoing neurosurgery under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the sensory evoked potentials (visual evoked potential, somatosensory evoked potential, auditory brainstem response) under remimazolam anesthesia with sensory evoked potentials under propofol anesthesia.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Amplitudes of visual evoked potentials and somatosensory evoked potentials. The latency of auditory brainstem response.
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
| 20 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing neurosurgery under general anesthesia.
Key exclusion criteria
Patients with impaired consciousness
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Ryusuke |
| Middle name | |
| Last name | Tanaka |
Organization
Ina central hospital
Division name
Division of anesthesiology
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina City, Nagano 396-8555, Japan
TEL
0265723121
rtanaka@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryusuke |
| Middle name | |
| Last name | Tanaka |
Organization
Ina central hospital
Division name
Division of anesthesiology
Zip code
396-8555
Address
1313-1 Koshiroukubo, Ina City, Nagano 396-8555, Japan
TEL
0265723121
Homepage URL
rtanaka@shinshu-u.ac.jp
Sponsor or person
Institute
Ina central hospital
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
Ethical review board of Ina central hospital
Address
1313-1 Koshiroukubo, Ina City, Nagano 396-8555, Japan
Tel
0265723121
info@inahp.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
伊那中央病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 11 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
10
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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 17 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 17 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2020 | Year | 11 | Month | 17 | Day |
Last modified on
| 2021 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048477
