UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022291 |
|---|---|
| Receipt number | R000018632 |
| Scientific Title | The relationship between end-tidal sevoflurane concentration and threshold current of motor-evoked potential(MEP) under general anesthesia with propofol and remifentanil |
| Date of disclosure of the study information | 2016/05/30 |
| Last modified on | 2023/04/14 10:53:30 |
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Basic information
Public title
The relationship between end-tidal sevoflurane concentration and threshold current of motor-evoked potential(MEP) under general anesthesia with propofol and remifentanil
Acronym
The relationship between end-tidal sevoflurane concentration and threshold current of motor-evoked potential(MEP)
Scientific Title
The relationship between end-tidal sevoflurane concentration and threshold current of motor-evoked potential(MEP) under general anesthesia with propofol and remifentanil
Scientific Title:Acronym
The relationship between end-tidal sevoflurane concentration and threshold current of motor-evoked potential(MEP)
Region
| Japan |
Condition
Condition
spine surgery
Classification by specialty
| Orthopedics | Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To demonstrate the relationship between concentration of end-tidal sevoflurane and MEP threshold current under general anesthesia.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Sevoflurane is combined at end-tidal concentration of 0.5, 1, 1.5 and 2% with propofol and remifentanil for general anesthesia and MEP threshold current is measured respectively after five minutes steady state.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Sevoflurane is combined at end-tidal concentration of 0.5, 1, 1.5 and 2% with propofol and remifentanil for general anesthesia and MEP threshold current is measured respectively.
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
| 18 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients undergoing spine surgery
Key exclusion criteria
Patients with motor palarysis
Patients with comorbidity American Society of Anesthesiologists physical status(ASA-PS)3 or more
Patients whom investigators consider to be ineligible
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | TAKEHIKO |
| Middle name | |
| Last name | NAGAOKA |
Organization
Shin-yurigaoka General Hospital
Division name
Anesthesia
Zip code
2150026
Address
255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL
0443229991
takeitezzz@gmail.com
Public contact
Name of contact person
| 1st name | TAKEHIKO |
| Middle name | |
| Last name | NAGAOKA |
Organization
Shin-yurigaoka General Hospital
Division name
Anesthesia
Zip code
2150026
Address
255 furusawa-toko, Asao, Kawasaki, Kanagawa
TEL
0443229991
Homepage URL
takeitezzz@gmail.com
Sponsor or person
Institute
Shin-yurigaoka general hospital
Institute
Department
Personal name
Funding Source
Organization
Our institution
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
Shin-Yurigaoka General Hospital
Address
255 Furusawatoko, Asao, Kawasaki, Kanagawa, Japan
Tel
0443229991
shinyuri_info@mt.strins.or.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
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 05 | Month | 30 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 05 | Month | 12 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018632
