UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035799 |
|---|---|
| Receipt number | R000040783 |
| Scientific Title | Effect of neuromuscular blockage status on intraoperative MEPs monitoring during spinal surgery: A retrospective observational study |
| Date of disclosure of the study information | 2019/03/01 |
| Last modified on | 2023/04/05 14:30:41 |
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Basic information
Public title
Effect of neuromuscular blockage status on intraoperative MEPs monitoring during spinal surgery: A retrospective observational study
Acronym
NARAMEDs Study
Scientific Title
Effect of neuromuscular blockage status on intraoperative MEPs monitoring during spinal surgery: A retrospective observational study
Scientific Title:Acronym
NARAMEDs Study
Region
| Japan |
Condition
Condition
The condition required spinal surgery
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Relationship between first TOF ratios recorded after finishing MEPs setting and patient characteristics
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
TOF ratio
Successful initiation of MEP
MEP amplitude
Effect on MEP amplitude amplification
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 20 | years-old | <= |
Age-upper limit
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Patients aged 20-85 years between April 2013 and March 2018
2) Patients who underwent myogenic MEPs monitoring under total intravenous anesthesia during spinal surgery (corrective fixation of scoliosis, spinal tumor removal, laminoplasty, posterior fusion, fenestration, etc.)
3) Patients receiving rocuronium at the time of tracheal intubation
4) Patients whose TOF ratio was measured by EMG at the same time as MEPs monitoring
Key exclusion criteria
1) Patients receiving the following medications known to affect neuromuscular function
- Anti-epileptic drug
- Oral steroid
Target sample size
160
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | KAWAGUCHI |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8522
Address
840 Shijocho, Kashihara, Nara
TEL
0744-22-3051
JPRWESeRWEDATABASEREGISTRATION@iqvia.com
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | SATO |
Organization
IQVIA Services Japan K.K.
Division name
Real World and Late Phase Research
Zip code
108-0074
Address
Keikyu Dai1 Bldg, 4-10-18 Takanawa, Minato-ku, Tokyo 108-0074
TEL
03-6859-9500
Homepage URL
JPRWESeRWEDATABASEREGISTRATION@iqvia.com
Sponsor or person
Institute
MSD Japan K.K.
Institute
Department
Personal name
Funding Source
Organization
MSD JAPAN K.K. Medical Affairs
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nara Medical University Medical Ethics Committee
Address
840 Shijo-machi, Kashihara, Nara, 634-8522 Japan
Tel
0744-29-8440
icats@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
奈良県立医科大学病院（奈良県）
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 03 | Month | 01 | Day |
Related information
URL releasing protocol
NA
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/36181124/
Number of participants that the trial has enrolled
366
Results
Published
Results date posted
| 2022 | Year | 11 | Month | 21 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The publication will be delayed because the final analysis was delayed
Date of the first journal publication of results
| 2022 | Year | 09 | Month | 30 | Day |
Baseline Characteristics
Eligible patients were aged between 20 and 85 years, had undergone spine surgery (e.g., corrective fixation of scoliosis, spinal tumor removal, laminoplasty, posterior fusion, or fenestration) with myogenic MEP monitoring under total intravenous anesthesia at Nara Medical University within the data collection period, had received rocuronium prior to endotracheal intubation, had TOF measured by electromyography at the same time as MEP monitoring, and had provided informed consent to participate in this study. Patients were excluded if they were receiving anti-epileptic drugs or oral steroids at the time of spine surgery, as these drugs are known to affect neuromuscular function.
Participant flow
Of the 366 patients who consented to participate at enrollment, 18 patients were excluded, and the analysis population consisted of 348 patients and 373 cases. Of these cases, there were 221 cases of sugammadex administration and 152 cases of spontaneous recovery.
Adverse events
Not Applicable
Outcome measures
The first primary objective was to determine the effect different patient background factors had on NMB by evaluating the TOF ratio after finishing the MEP setting (i.e., at baseline). In addition, the second primary objective was to investigate the relationship between the TOF ratio category at baseline and MEP amplitude, which was evaluated using the MEP detection success rate after finishing the MEP setting (i.e., at baseline). Successful MEP detection was defined as successful detection at the left and right abductor pollicis brevis and abductor hallucis muscles, as well as detection at 2 or more left and right tibialis anterior and soleus muscles.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 08 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 15 | Day |
Date of closure to data entry
| 2019 | Year | 10 | Month | 25 | Day |
Date trial data considered complete
| 2020 | Year | 09 | Month | 01 | Day |
Date analysis concluded
| 2020 | Year | 11 | Month | 20 | Day |
Other
Other related information
to explore factors affecting the first TOF ratio recorded after finishing MEPs setting and factors associated with the effect of intraoperative amplification of MEPs amplitude by sugammadex
Management information
Registered date
| 2019 | Year | 02 | Month | 07 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040783
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