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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000041003
Receipt No. R000037756
Scientific Title Evaluation of Reliability of Post-Tetanic Motor-Evoked Potential Monitoring Under Desflurane Anesthesia
Date of disclosure of the study information 2020/07/05
Last modified on 2020/07/05

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Basic information
Public title Evaluation of Reliability of Post-Tetanic Motor-Evoked
Potential Monitoring Under Desflurane Anesthesia
Acronym Post-Tetanic Motor-Evoked Potential Monitoring Under Desflurane Anesthesia
Scientific Title Evaluation of Reliability of Post-Tetanic Motor-Evoked
Potential Monitoring Under Desflurane Anesthesia
Scientific Title:Acronym Post-Tetanic Motor-Evoked Potential Monitoring Under Desflurane Anesthesia
Region
Japan

Condition
Condition Lumbar diseases
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Compare the reliability of post-tetanic motor-evoked potential (p-MEP) monitoring under desflurane anesthesia with that of conventional MEP (c-MEP).
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Both c-MEP and p-MEP monitoring were performed throughout the operation in each patient. For recording c-MEPs, transcranial electrical train of five pulses stimulation with an interstimulus interval of 1 second was performed and CMAP were bilaterally recorded from abductor pollicis brevis, abductor hallucis, tibialis anterior, and soleus muscles. For recording p-MEPs, tetanic stimulation (50 Hz, 50 mA, 5 sec) was applied to the left median nerve and bilateral tibial
nerves 1 second before transcranial stimulation and CMAPs were recorded from the same muscles. The false positive, false negative, and accuracy of MEP monitoring in the detection of change in motor function were compared between p-MEP and c-MEP.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Desflurane
Interventions/Control_2 post-tetanic stimulation
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 Lumbar diseases patients over 20 years old
Key exclusion criteria emergency cases, trauma cases, with CSM cases, infection cases, epilepsia cases, pace maker cases, who rejected to join the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name Sachiko
Middle name
Last name Kawasaki
Organization Nara Medical University
Division name Orthopedic surgery
Zip code 6340813
Address 840 Shijyocho, Kashihara, Nara
TEL 0744-22-3051
Email sachi-kawa@naramed-u.ac.jp

Public contact
Name of contact person
1st name Sachiko
Middle name
Last name Kawasaki
Organization Nara Medical University
Division name Orthopedic surgery
Zip code 6340813
Address 840 Shijyocho, Kashihara, Nara
TEL 0744-22-3051
Homepage URL
Email sachi-kawa@naramed-u.ac.jp

Sponsor
Institute Nara Medical University
Institute
Department

Funding Source
Organization Nara Medical University
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 Nara Medical University
Address 840 Shijyocho, Kashihara, Nara
Tel 0744-22-3051
Email sachi-kawa@naramed-u.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

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 05 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 40
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 No longer recruiting
Date of protocol fixation
2018 Year 07 Month 04 Day
Date of IRB
2018 Year 07 Month 16 Day
Anticipated trial start date
2018 Year 08 Month 22 Day
Last follow-up date
2021 Year 08 Month 21 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 07 Month 05 Day
Last modified on
2020 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037756

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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