UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034884 |
|---|---|
| Receipt number | 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 | 2022/05/23 11:34:49 |
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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
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
hhoshi6@gmail.com
Sponsor or person
Institute
Saitama Medical University Hospital, Anesthesiology, 38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Institute
Department
Personal name
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
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
Unresearched
Publication of results
Unpublished
Result
URL related to results and publications
Unresearched
Number of participants that the trial has enrolled
0
Results
Unresearched
Results date posted
| 2022 | Year | 05 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unresearched
Participant flow
Unresearched
Adverse events
Unresearched
Outcome measures
Unresearched
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2019 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 04 | Month | 02 | Day |
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
| 2022 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039749
