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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034884
Receipt No. R000039749
Scientific Title An association between intraoperative motor/ somatosensory evoked potential and anesthesia drugs
Date of disclosure of the study information 2019/04/01
Last modified on 2019/03/13

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Basic information
Public title An association between intraoperative motor/ somatosensory evoked potential and anesthesia drugs
Acronym An association between intraoperative motor evoked potential and anesthesia drugs
Scientific Title An association between intraoperative motor/ somatosensory evoked potential and anesthesia drugs
Scientific Title:Acronym An association between intraoperative motor evoked potential and anesthesia drugs
Region
Japan

Condition
Condition Patients aged 20 years or older who undergo spinal surgery using MEP or SEP under general anesthesia.
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We measure how much anesthetic agents used for general anesthesia affect the amplitude of motor evoked potential (MEP) or somatosensory Evoked Potentials (SEP).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in MEP and SEP
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Randomized
Randomization unit Cluster
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Prevention
Type of intervention
Medicine
Interventions/Control_1 propofol 1-5
Interventions/Control_2 Sevoflurane 1-3%
Interventions/Control_3 Desflurane 1-3%
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 Patient with ASA 1-2 who is over 20 years old who undergoes spinal surgery using MEP under general anesthesia.
Key exclusion criteria Patient twenty years or younger.
Patient with poor general condition.
Patients who can not measure the control value of MEP.
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Hiroshi
Middle name
Last name Hoshijima
Organization Saitama Medical University Hospital
Division name Anesthesiology
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL 049-276-1271
Email hhoshi6@gmail.com

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Hoshijima
Organization Saitama Medical University Hospital
Division name Anesthesiology
Zip code 350-0495
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL 049-276-1271
Homepage URL
Email hhoshi6@gmail.com

Sponsor
Institute Saitama Medical University Hospital, Anesthesiology, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Institute
Department

Funding Source
Organization Saitama Medical University Hospital, Anesthesiology, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Saitama Medical University Hospital
Address 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Tel 049-276-1271
Email hhoshi6@gmail.com

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
2019 Year 04 Month 01 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 Preinitiation
Date of protocol fixation
2019 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2019 Year 04 Month 02 Day
Last follow-up date
2021 Year 04 Month 01 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 11 Month 14 Day
Last modified on
2019 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039749

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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