UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031650 |
|---|---|
| Receipt number | R000035653 |
| Scientific Title | The effect of propofol on H Reflex, M wave and motor evoked potential. |
| Date of disclosure of the study information | 2018/03/19 |
| Last modified on | 2020/01/28 11:42:19 |
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Basic information
Public title
The effect of propofol on H Reflex, M wave and motor evoked potential.
Acronym
The effect of propofol on H Reflex, M wave and motor evoked potential.
Scientific Title
The effect of propofol on H Reflex, M wave and motor evoked potential.
Scientific Title:Acronym
The effect of propofol on H Reflex, M wave and motor evoked potential.
Region
| Japan |
Condition
Condition
Patients who are scheduled for spine surgery by posterior approach requiring neurophysiological monitoring under general anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The analysis of effect of propofol on motor system.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The amplitude of H reflex of left soleus muscle at propofol effect site concentration 2.0 and 4.0 mcg/ml.
Key secondary outcomes
The amplitude and latency of motor evoked potential, M wave and F wave in bilateral soleus muscle at three propofol concentration(effect site concentrations 2.0, 3.0 and 4.0 mcg/ml).
The amplitude and latency of H Reflex in left soleus muscle at propofol concentration(effect site concentrations) 3.0 mcg/ml.
The latency of H Reflex in left soleus muscle at three propofol concentration(effect site concentrations 2.0, 3.0 and 4.0 mcg/ml).
The amplitude and latency of H Reflex in right soleus muscle at three propofol concentration(effect site concentrations 2.0, 3.0 and 4.0 mcg/ml).
The amplitude and latency of motor evoked potential in bilateral abductor pollicis brevis, bilateral quadriceps, bilateral tibialis anterior, bilateral abductor hallucis and bilateral hamstrings at three propofol concentration(effect site concentrations 2.0, 3.0 and 4.0 mcg/ml).
The amplitude and latency of posterior tibial nerve somatosensory evoked potential at three propofol concentration(effect site concentrations 2.0, 3.0 and 4.0 mcg/ml).
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
Measurement of H Reflex, M wave, F wave, and motor evoked potentials at three effect site concentrations (2.0, 3.0 and 4.0 mcg/ml) of propofol.
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Adult patients who are scheduled for spine surgery by posterior approach requiring intraoperative neurophysiological monitoring.
Key exclusion criteria
ASA PS 4 or 5.
Previous history of epilepsy, cerebrovascular diseases
History of neuromuscular disorders including myasthenia gravis, lower extremity peripheral nerve dysfunction, severe heart disease.
Those who can not understand the purpose of this study such as dementia.
Those who are allergic to the drugs to be used.
Those who are judged unsuitable by the research doctor.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Baba |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
951-8122
Address
1-754, Asahi-machi-Dori, Chuo-ku, Niigata city, Niigata, Japan
TEL
025-227-2328
masui@med.niigata-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Deguchi |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Division of Anesthesiology
Zip code
951-8122
Address
1-754, Asahi-machi-Dori, Chuo-ku, Niigata city, Niigata, Japan
TEL
025-227-2328
Homepage URL
asabekkamu1@gmail.com
Sponsor or person
Institute
Niigata University
Institute
Department
Personal name
Funding Source
Organization
Japan society for the promotion of science
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Committee, niigata univercity
Address
1-754, Asahi-machi-Dori, Chuo-ku, Niigata city, Niigata, 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(新潟県)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 03 | Month | 19 | 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
Completed
Date of protocol fixation
| 2018 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2018 | Year | 02 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 03 | Month | 19 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 27 | Day |
Date of closure to data entry
| 2020 | Year | 01 | Month | 28 | Day |
Date trial data considered complete
| 2020 | Year | 01 | Month | 28 | Day |
Date analysis concluded
| 2020 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 03 | Month | 09 | Day |
Last modified on
| 2020 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035653
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
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