UMIN試験ID | UMIN000041310 |
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受付番号 | R000047168 |
科学的試験名 | |
一般公開日(本登録希望日) | 2020/10/01 |
最終更新日 | 2023/08/07 09:30:04 |
日本語
英語
Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
日本語
英語
Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
日本語
英語
Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
日本語
英語
Development of a new device for improving accuracy and feasibility in neuromuscular monitoring with acceleromyography: a prospective randomized trial
アジア(日本以外)/Asia(except Japan) |
日本語
英語
neuromuscular blockade monitoring during lumbar spinal surgery
麻酔科学/Anesthesiology |
悪性腫瘍以外/Others
いいえ/NO
日本語
英語
To compare the precision and performance of
acceleromyography performed with the aid of a newly developed wrist brace
with standard electromyography (EMG).
その他/Others
日本語
英語
To compare the precision and performance of
acceleromyography performed with the aid of a newly developed wrist brace
with standard electromyography (EMG).
日本語
英語
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.
日本語
英語
The difference (agreement) of the two groups (with brace and without brace) against the EMG (Bland-Altman plots).
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
試験参加者がブラインド化されている単盲検/Single blind -participants are blinded
実薬・標準治療対照/Active
2
診断/Diagnosis
医療器具・機器/Device,equipment |
日本語
英語
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.
日本語
英語
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.
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
日本語
英語
18 | 歳/years-old | より上/< |
75 | 歳/years-old | 未満/> |
男女両方/Male and Female
日本語
英語
Patients with ASA physical status 1-2, undergoing elective lumbar spine surgery.
日本語
英語
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.
60
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | Byung Gun |
ミドルネーム | |
姓 | Lim |
日本語
英語
Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital
日本語
英語
Seoul
08308
日本語
英語
148, Gurodong-ro, Guro-gu, Seoul, Republic of Korea
82-2-2626-3231
bglim9205@korea.ac.kr
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | Seok Kyeong |
ミドルネーム | |
姓 | Oh |
日本語
英語
Department of Anesthesiology and Pain Medicine, Korea University Guro Hospital
日本語
英語
Seoul
08308
日本語
英語
148, Gurodong-ro, Guro-gu, Seoul, Republic of Korea
82-2-2626-1437
nanprayboy@korea.ac.kr
日本語
その他
英語
Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
日本語
日本語
日本語
英語
日本語
その他
英語
Korea University Guro Hospital, Korea University College of Medicine, Seoul, Republic of Korea
日本語
日本語
その他/Other
日本語
英語
日本語
英語
日本語
英語
日本語
英語
Korea University Guro Hospital Institutional Review Board, Seoul, Republic of Korea
日本語
英語
Korea University Guro Hospital, 148, Gurodong-ro, Guro-gu, Seoul 08308, Republic of Korea
82-2-2626-1632
kughirb@naver.com
いいえ/NO
日本語
英語
日本語
英語
2020 | 年 | 10 | 月 | 01 | 日 |
https://link.springer.com/article/10.1007/s10877-023-01000-w
最終結果が公表されている/Published
https://link.springer.com/article/10.1007/s10877-023-01000-w
57
日本語
英語
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.
2023 | 年 | 08 | 月 | 07 | 日 |
日本語
英語
2023 | 年 | 04 | 月 | 01 | 日 |
日本語
英語
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.
日本語
英語
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.
日本語
英語
No severe adverse event.
日本語
英語
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.
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英語
日本語
英語
試験終了/Completed
2019 | 年 | 11 | 月 | 01 | 日 |
2019 | 年 | 11 | 月 | 12 | 日 |
2019 | 年 | 11 | 月 | 12 | 日 |
2021 | 年 | 05 | 月 | 06 | 日 |
2021 | 年 | 12 | 月 | 12 | 日 |
2022 | 年 | 05 | 月 | 01 | 日 |
2022 | 年 | 05 | 月 | 01 | 日 |
日本語
英語
2020 | 年 | 08 | 月 | 04 | 日 |
2023 | 年 | 08 | 月 | 07 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000047168
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047168
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