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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035799
Receipt No. 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 2019/02/07

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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
Middle name
Last name KAWAGUCHI, Masahiko
Organization Nara Medical University
Division name Department of Anesthesiology
Zip code
Address 840 Shijocho, Kashihara, Nara
TEL 0744-22-3051
Email JPN.NARAMEDs@iqvia.com

Public contact
Name of contact person
1st name
Middle name
Last name SATO, Takashi
Organization IQVIA Services Japan K.K.
Division name Real World and Late Phase Research
Zip code
Address Keikyu Dai1 Bldg, 4-10-18 Takanawa, Minato-ku, Tokyo 108-0074
TEL 03-6859-9500
Homepage URL
Email JPN.NARAMEDs@iqvia.com

Sponsor
Institute MSD Japan K.K.
Institute
Department

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
Address
Tel
Email

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
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 Preinitiation
Date of protocol fixation
2018 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2019 Year 03 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

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
2019 Year 02 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040783

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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