UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034168 |
|---|---|
| Receipt number | R000038951 |
| Scientific Title | The effects of desflurane and propofol on motor evoked potential in patients undergoing spine surgery |
| Date of disclosure of the study information | 2018/09/18 |
| Last modified on | 2021/09/24 10:40:25 |
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Basic information
Public title
The effects of desflurane and propofol on motor evoked potential in patients undergoing spine surgery
Acronym
The effect of desflurane on motor evoked potential
Scientific Title
The effects of desflurane and propofol on motor evoked potential in patients undergoing spine surgery
Scientific Title:Acronym
The effect of desflurane on motor evoked potential
Region
| Japan |
Condition
Condition
Patients with ASA status 1 or 2, who are more than or equal to 20 years old and undergo spine surgery under motor evoked potential (MEP) monitoring
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the suppressive effects of desflurane and propofol on MEP, and demonstrate the safety of desflurane in adult patienst undergoing spine surgery
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The intensity of electronic stimulation at first MEP evaluation
Key secondary outcomes
MEP amplitude at first evaluation
The intensity of electronic stimulation and MEP amplitude after first MEP evaluation
The frequency of MEP amplitude reduction or disappearance after first MEP evaluation
The number of patients who presented MEP reduction or disappearance during operation and paralysis after operation
Time to extubation from the end of surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention:
General anesthesia using desflurane(0.5-1.5MAC)
Interventions/Control_2
Control:
General anesthesia using propofol(Target controlled infusion:1.5 -4.0 microgram/ml)
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patient with ASA status 1 or 2, who are more than or equal to 20 years old and undergo spine surgery
Key exclusion criteria
Patients with past history or family history of malignant hyperthermia
Patients with allergy to desflurane or propofol
Patients with paralysis of upper or lower limbs before surgery
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Morisaki |
Organization
Keio University School of Medicine
Division name
Department of Anesthesiology
Zip code
160-8582
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
TEL
03-3353-1211
morisaki@z8.keio.jp
Public contact
Name of contact person
| 1st name | Takeshi |
| Middle name | |
| Last name | Suzuki |
Organization
Tokai University School of Medicine
Division name
Department of Anesthesiology
Zip code
259-1193
Address
143 Shimokasuya, Isehara, Kanagawa, Japan
TEL
0463-93-1121
Homepage URL
takeshi-su@a7.keio.jp
Sponsor or person
Institute
Department of Anesthesiology, Keio University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Keio University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee, Keio University School of Medicine
Address
35 Shinanomachi, Shinjuku-ku, Tokyo, Japan
Tel
03-5363-3611
med-rinri-jimu@adst.keio.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
慶應義塾大学病院(東京都)
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 09 | Month | 18 | 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
Terminated
Date of protocol fixation
| 2018 | Year | 08 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 09 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 19 | Day |
Last follow-up date
| 2022 | 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 | 09 | Month | 16 | Day |
Last modified on
| 2021 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038951
