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Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000031650
Receipt No. 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 2019/03/12

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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
Email 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
Email asabekkamu1@gmail.com

Sponsor
Institute Niigata University
Institute
Department

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
Email 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 Open public recruiting
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 03 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
2018 Year 03 Month 09 Day
Last modified on
2019 Year 03 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035653

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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