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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000041310
Receipt No. R000047168
Scientific Title Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
Date of disclosure of the study information 2020/10/01
Last modified on 2020/08/04

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Basic information
Public title Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
Acronym Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
Scientific Title Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
Scientific Title:Acronym Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
Region
Asia(except Japan)

Condition
Condition neuromuscular blockade monitoring during lumbar spinal surgery
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the precision and performance of
acceleromyography performed with the aid of a newly developed wrist brace
with standard electromyography (EMG).
Basic objectives2 Others
Basic objectives -Others To compare the precision and performance of
acceleromyography performed with the aid of a newly developed wrist brace
with standard electromyography (EMG).
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The precision (i.e., variance during recovery to at least an accelomyographic TOF 0.90) between the group with brace and the group without brace compared with EMG.
Key secondary outcomes The difference (agreement) of the two groups (with brace and without brace) against the EMG (Bland-Altman plots).

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Device,equipment
Interventions/Control_1 Neuromuscular transmission monitoring during baseline, onset and spontaneous recovery of rocuronium-induced neuromuscular block using accelomyography with wrist brace/Neuromuscular transmission monitoring during baseline, onset and spontaneous recovery of rocuronium-induced neuromuscular block using EMG.
Interventions/Control_2 Neuromuscular transmission monitoring during baseline, onset and spontaneous recovery of rocuronium-induced neuromuscular block using accelomyography without wrist brace/Neuromuscular transmission monitoring during baseline, onset and spontaneous recovery of rocuronium-induced neuromuscular block using EMG.
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
18 years-old <
Age-upper limit
75 years-old >
Gender Male and Female
Key inclusion criteria Patients with ASA physical status 1-2, undergoing elective lumbar spine surgery.
Key exclusion criteria Patients were excluded if they had a known hypersensitivity to the drugs used in this study, known neuromuscular disease, significant hepatic or renal dysfunction, cerebrovascular disease, or a body mass index >30.0 kg m-2.
Patients with hemodynamic instability with an increase or decrease in blood pressure of 30% or more of the baseline over 15 minutes during surgery, and blood loss of 1L or more during surgery.
Target sample size 60

Research contact person
Name of lead principal investigator
1st name Byung Gun
Middle name
Last name Lim
Organization Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital
Division name Seoul
Zip code 08308
Address 148, Gurodong-ro, Guro-gu, Seoul, Republic of Korea
TEL 82-2-2626-3231
Email bglim9205@korea.ac.kr

Public contact
Name of contact person
1st name Seok Kyeong
Middle name
Last name Oh
Organization Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital
Division name Seoul
Zip code 08308
Address 148, Gurodong-ro, Guro-gu, Seoul, Republic of Korea
TEL 82-2-2626-1437
Homepage URL
Email nanprayboy@korea.ac.kr

Sponsor
Institute Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
Institute
Department

Funding Source
Organization Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
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 Korea University Guro Hospital Institutional Review Board, Seoul, Republic of Korea
Address Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul 08308, Republic of Korea
Tel 82-2-2626-1632
Email kughirb@naver.com

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 10 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 Enrolling by invitation
Date of protocol fixation
2019 Year 11 Month 01 Day
Date of IRB
2019 Year 11 Month 12 Day
Anticipated trial start date
2019 Year 11 Month 12 Day
Last follow-up date
2020 Year 08 Month 01 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 08 Month 04 Day
Last modified on
2020 Year 08 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047168

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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