UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041003 |
|---|---|
| Receipt number | 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 | 2024/01/07 09:52:16 |
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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
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
sachi-kawa@naramed-u.ac.jp
Sponsor or person
Institute
Nara Medical University
Institute
Department
Personal name
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
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
https://naraseikei.com/
Publication of results
Unpublished
Result
URL related to results and publications
https://naraseikei.com/
Number of participants that the trial has enrolled
46
Results
The MEP recording success rates for GC and Quad were inadequate under general anesthesia with 4% desflurane. However, bilateral median nerve tetanic stimulation can effectively augment MEP safely under general anesthesia with high-concentration desflurane in patients who undergo spinal surgery.
Results date posted
| 2023 | Year | 07 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients who were scheduled to undergo lumbar surgery
Participant flow
Anesthesia was maintained with an end-tidal concentration of 4% desflurane and remifentanil. Compound muscle action potentials were recorded bilaterally from the abductor pollicis brevis, abductor hallucis, tibialis anterior, gastrocnemius (GC), and quadriceps (Quad). For post-tetanic MEPs (p-MEPs), tetanic stimulation was applied to the median nerves (p-MEPm) or tibial nerves (p-MEPt) bilaterally before transcranial stimulation.
Adverse events
None
Outcome measures
success rate
amplitude
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2023 | Year | 12 | Month | 31 | Day |
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
| 2024 | Year | 01 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037756
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