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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000034168
Receipt No. 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 2019/09/16

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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
Email 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
Email takeshi-su@a7.keio.jp

Sponsor
Institute Department of Anesthesiology, Keio University School of Medicine
Institute
Department

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
Email 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 Enrolling by invitation
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
2019 Year 09 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038951

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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