UMIN試験ID | UMIN000035102 |
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受付番号 | R000040013 |
科学的試験名 | |
一般公開日(本登録希望日) | 2018/12/01 |
最終更新日 | 2018/12/01 23:52:25 |
日本語
英語
OPTIMALISATION OF REVERSAL CLINICAL STRATEGY WITHOUT TOF MONITORING IS EQUIVALENT TO REVERSAL CLINICAL STRATEGY USING QUANTITATIVE TOF MONITORING?
COMPARISON STUDY ON INCIDENCE OF RESIDUAL PARALYSIS AT RECOVERY ROOM FOR PATIENTS RECEIVING ROCURONIUM AND SEVOFLURANE
日本語
英語
OPTIMIZED REVERSAL WITHOUT TOF MONITORING VERSUS REVERSAL USING QUANTITATIVE TOF MONITORING:
AN EQUIVALENCE STUDY
日本語
英語
OPTIMALISATION OF REVERSAL CLINICAL STRATEGY WITHOUT TOF MONITORING IS EQUIVALENT TO REVERSAL CLINICAL STRATEGY USING QUANTITATIVE TOF MONITORING?
COMPARISON STUDY ON INCIDENCE OF RESIDUAL PARALYSIS AT RECOVERY ROOM FOR PATIENTS RECEIVING ROCURONIUM AND SEVOFLURANE
日本語
英語
OPTIMIZED REVERSAL WITHOUT TOF MONITORING VERSUS REVERSAL USING QUANTITATIVE TOF MONITORING:
AN EQUIVALENCE STUDY
アジア(日本以外)/Asia(except Japan) |
日本語
英語
Intubated patients under general anesthesia using sevoflurane and rocuronium
麻酔科学/Anesthesiology |
悪性腫瘍以外/Others
いいえ/NO
日本語
英語
Optimizing neostigmine reversal strategy has never been studied. Therefore, the authors would like to see whether optimization of neostigmine reversal clinical strategy without TOF monitoring is equivalent to neostigmine reversal strategy using TOF monitoring. From this study, the authors may provide recommendations to clinicians who have limitations in the availability of peripheral nerve stimulation device and sugammadex.
安全性・有効性/Safety,Efficacy
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英語
探索的/Exploratory
説明的/Explanatory
該当せず/Not applicable
日本語
英語
the proportion of subjects who have residual paralysis in the recovery room based on the threshold value <0.90
日本語
英語
the proportion of subjects who have airway problems, respiration patterns, oxygen saturation, nausea and vomiting during 30 minutes in the recovery room
介入/Interventional
並行群間比較/Parallel
ランダム化/Randomized
個別/Individual
オープンだが測定者がブラインド化されている/Open -but assessor(s) are blinded
実薬・標準治療対照/Active
はい/YES
2
予防・検診・検査/Prevention
医薬品/Medicine |
日本語
英語
For subjects in group A (without TOF monitoring), the first researcher counted the time since last rocuronium administration and assessed the subject's spontaneous breathing effort. Neostigmine dosing followed the protocol below:
a. Neostigmine was administered if the spontaneous breathing has been detected or the time since last rocuronium administration has exceeded 30 minutes.
b. The dose of neostigmine was based on the estimated depth of blockade:
The time since last rocuronium administration > 30 minutes, without evidence of spontaneous breathing effort: 50 mcg/kg and atropine sulfate 10 mcg/kg.
Minimal spontaneous breathing, and the time since last rocuronium administration <30 minutes: 30-40 mcg/kg and atropine sulfate 10 mcg/kg.
Minimal spontaneous breathing, and the time since last rocuronium administration > 30 minutes: 20-30 mcg/kg and atropine sulfate 10 mcg/kg.
Sufficient spontaneous breathing pattern: 10 mcg/kg and atropine sulfate 10 mcg/kg.
Extubation was carried out in group A at least 15 minutes after reversal attempt.
日本語
英語
For subjects in the group with TOF monitoring (group B), TOF stimulation was given without calibration with a stimulation of 50 mA. Measurements were carried out in 12 second cycle mode. Neostigmine was given at a dose according to the measured TOF value at the start of skin / muscle closure, as followed:
TOF 0-1 (intense block): delay giving neostigmine.
TOF 2-4 (moderate block): Neostigmine 50 mcg/kg and atropine sulfate 10 mcg/kg.
TOF ratio <=0.40 (mild block): Neostigmine 40 mcg/kg and atropine sulfate 10 mcg/kg.
TOF ratio 0.40-0.70 (minimal block): Neostigmine 20-30 mcg/kg and atropine sulfate 10 mcg/kg.
TOF ratio 0.70-0.90 (minimal block): Neostigmine 10 mcg/kg and atropine sulfate 10 mcg/kg
TOF ratio value >= 0.90 (fully recovered): Neostigmine should not be given.
After the surgical procedure was complete and the TOF ratio >=0.90 in group B, the TOF device was detached and the subject was extubated.
日本語
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18 | 歳/years-old | より上/< |
60 | 歳/years-old | 未満/> |
男女両方/Male and Female
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英語
patients aged 18-60 years, with ASA 1-2 physical status who will undergo elective non-head/neck surgery below general anesthesia procedure intubation
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英語
elective surgery <1 hour duration; awake extubation or post-surgery intensive care admission; body mass index> 35 kg/m2; had hepatic disease (liver enzyme value> 50% normal value); renal insufficiency (serum creatinine>1.8 mg/dL), neuromuscular disease; consumption of drugs known to affect neuromuscular transmission; contraindications to neostigmine and or atropine sulfate; a history of hypersensitivity or allergic to neostigmine, rocuronium or anesthetic agent given; difficulty accessing the TOF measuring device in the ulnar nerve.
80
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | |
ミドルネーム | |
姓 | Ardyan Prima Wardhana |
日本語
英語
FACULTY OF MEDICINE, GADJAH MADA UNIVERSITY
日本語
英語
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE THERAPY
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英語
FARMAKO SEKIP UTARA, YOGYAKARTA, INDONESIA, 55281
6282138433032
ardyan.wardhana@yahoo.com
日本語
名 | |
ミドルネーム | |
姓 |
英語
名 | |
ミドルネーム | |
姓 | Ardyan Prima Wardhana |
日本語
英語
FACULTY OF MEDICINE, GADJAH MADA UNIVERSITY
日本語
英語
DEPARTMENT OF ANESTHESIOLOGY AND INTENSIVE THERAPY
日本語
英語
FARMAKO SEKIP UTARA, YOGYAKARTA, INDONESIA, 55281
6282138433032
ardyan.wardhana@yahoo.com
日本語
その他
英語
RSUP Dr. Sardjito Yogyakarta
日本語
日本語
日本語
英語
日本語
その他
英語
RSUP Dr. Sardjito Yogyakarta
日本語
日本語
その他/Other
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いいえ/NO
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2018 | 年 | 12 | 月 | 01 | 日 |
未公表/Unpublished
日本語
英語
Six (16.7%) residual paralysis in the recovery room occurred in group A, while one case (2.8%) occurred in group B (p=0.107; 95%CI 0.01; 0.27). No subjects had TOF ratio <0.70 in the recovery room. The TOF ratio in the recovery room did not differ between two groups (p=0.053; 95%CI -5.20; 0.29). However, the reversal-extubation time in group A was longer than in group B. The absolute difference in the proportion of residual paralysis in the recovery room was 13.9% (95%CI 6%; 27.2%). The equivalence test showed that the 95% confidence interval of this study is partly outside the range of equivalence margin (15%). One respiratory adverse event in the recovery room was found in this study.
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試験終了/Completed
2018 | 年 | 02 | 月 | 01 | 日 |
2018 | 年 | 05 | 月 | 01 | 日 |
2018 | 年 | 07 | 月 | 31 | 日 |
2018 | 年 | 07 | 月 | 31 | 日 |
2018 | 年 | 08 | 月 | 10 | 日 |
2018 | 年 | 09 | 月 | 26 | 日 |
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2018 | 年 | 12 | 月 | 01 | 日 |
2018 | 年 | 12 | 月 | 01 | 日 |
日本語
https://center6.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000040013
英語
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040013
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