Evaluation of Accelerometer-Based Neuromuscular Monitoring Reliability to Exclude Postoperative Residual Paralysis
Accelerometer-based neuromuscular monitoring is not the gold-standard method to evaluate residual postoperative paralysis but it represents the most simple, inexpensive and widespread tool in clinical practice. Train-of-four ratio (TOF-ratio) of 100% is considered the gold-standard to avoid PORC (post operative residual curarization).
This clinical trial is conducted to verify the reliability of accelerometer-based neuromuscular monitoring in order to exclude postoperative residual paralysis which is not highlighted by this instrument at a TOF-ratio=100%.
The study evaluates patients' neuromuscular recovery evaluated using pulmonary function tests after extubation at a TOFratio=100%. Administering placebo or sugammadex at a TOF ratio=100% allows to evaluate whether the recovery of muscle function is concrete, although the monitoring device shows a complete decurarization; patients treated with sugammadex should not be capable to perform better pulmonary function tests if a TOF ratio=100% is reliable.
調査の概要
詳細な説明
From the beginning of the surgery to the time of extubation neuromuscular block is monitored with accelerographic monitor TOF-Watch SX. Patients are extubated when TOF-ratio is 100%.
Patients will perform pulmonary function tests (PFTs):
- the day ahead of surgery (for elegibility and training)
- 60 minutes before surgery
- 10 minutes after extubation
- 5 minutes after sugammadex or placebo administration
- 20 minutes after sugammadex or placebo administration.
The following parameters will be evaluated and compared between the 2 groups:
- Maximal Inspiratory Pressure (MIP)
- Maximal Expiratory Pressure (MEP)
- Forced Expiratory Volume in the first Second (FEV1)
- Forced Vital Capacity (FVC)
- Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50)
- PaO2, PaCO2, pH
- heart rate, blood pressure and respiratory rate
Changes of pulmonary tests performed before and after sugammadex or placebo will be compared between study groups.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Milan、イタリア
- Fondazione IRCCS Istituto Nazionale dei Tumori
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
- patients undergoing major abdominal surgery
- age between 18 and 70 years
- ASA class 1 or 2
- patients scheduled for blended anesthesia (epidural + general anesthesia)
- patients capable to perform pulmonary function tests (preoperative values of MIP, MEP, FEV1% and FEV1/FVC in normal ranges).
Exclusion Criteria:
- known or suspected respiratory, cardiovascular or neuromuscular disease
- renal or hepatic failure
- known or suspected allergies to drugs used in the study
- risk for malignant hyperthermia
- pregnancy
- diagnosed depressive disorder
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：トリプル
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
アクティブコンパレータ：スガマデクス
|
sugammadex 10 mg/ml diluted solution dosage: 1mg/kg i.v.
(0,1 ml/kg)
他の名前：
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プラセボコンパレーター：Sodium chloride solution
|
Sodium chloride solution 0,9% dosage: 0,1 ml/kg i.v.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Maximum Inspiratory Pressure (MIP) changes after placebo or sugammadex
時間枠：10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Maximum Expiratory Pressure (MEP) changes after placebo or sugammadex
時間枠：10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Forced Expiratory Volume after the first second (FEV1) changes after placebo or sugammadex
時間枠：10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Forced Vital Capacity (FVC) changes after placebo or sugammadex
時間枠：10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Ratio of Maximum Expiratory Flow and Maximum Inspiratory Flow rate at 50% of vital capacity (MEF50/MIF50) changes after placebo or sugammadex
時間枠：10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Hemogasanalysis parameters changes after placebo or sugammadex
時間枠：10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
|
Swallow ability changes after placebo or sugammadex
時間枠：10 minutes after surgery and 5 minutes later
|
10 minutes after surgery and 5 minutes later (after placebo or sugammadex administration)
|
10 minutes after surgery and 5 minutes later
|
協力者と研究者
捜査官
- スタディディレクター：Federico Piccioni, MD、Fondazione IRCCS Istituto Nazionale dei tumori - Milan
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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