UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041310 |
|---|---|
| Receipt number | 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 | 2023/08/07 09:30:04 |
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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
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
nanprayboy@korea.ac.kr
Sponsor or person
Institute
Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
Institute
Department
Personal name
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
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
https://link.springer.com/article/10.1007/s10877-023-01000-w
Publication of results
Published
Result
URL related to results and publications
https://link.springer.com/article/10.1007/s10877-023-01000-w
Number of participants that the trial has enrolled
57
Results
The agreement between AMG and EMG in each group was assessed using the Bland Altman method. In group B, the repeatability coefficient of T1 was significantly lower during the recovery to T1 of 25% and TOF ratio of 0.9 (P 0.017 and 0.033, respectively), indicating higher precision. The mean differences of bias between AMG and EMG in TOF ratio of 0.9 were 6.839 in group NB and 3.922 in group B. The wide limits of agreement in group NB was slightly narrowed in group B but without significance.
Results date posted
| 2023 | Year | 08 | Month | 07 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2023 | Year | 04 | Month | 01 | Day |
Baseline Characteristics
Patients aged 19 to 75 years with American Society of Anesthesiologists physical status I or II who underwent elective lumbar spine surgery were included. Patients were excluded if they had known hypersensitivity to the drugs used in this study, neuromuscular disease, significant hepatic or renal dysfunction, cerebrovascular disease, or body mass index > 30.0. Patients who required intraoperative neurophysiological monitoring, including motor-evoked potentials, were also excluded.
Participant flow
The patients were randomly assigned to groups in which AMG with a wrist brace (group B) or without a wrist brace (no brace; group NB) was applied to an arm using a web-based computer-generated list. The randomized numbers were kept in opaque, sealed envelopes and opened in the operating room by an independent anesthesiologist.
Adverse events
No severe adverse event.
Outcome measures
Fifty seven patients, undergoing lumbar surgery under general anesthesia, were randomly assigned to groups to which AMG was applied with or without (no) brace (29 in group B vs. 28 in group NB). EMG was performed in the contralateral arm. Repeatability coefficients of the first twitch height (T1) and TOF ratio were assessed from nine consecutive measurements during spontaneous recovery from rocuronium-induced neuromuscular block and the AMGs of the two groups were compared in prone position.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
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
| 2021 | Year | 05 | Month | 06 | Day |
Date of closure to data entry
| 2021 | Year | 12 | Month | 12 | Day |
Date trial data considered complete
| 2022 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2022 | Year | 05 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 04 | Day |
Last modified on
| 2023 | Year | 08 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047168
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