The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block (MagRoc)
The Effect of Magnesium Sulphate on the Time Course of Rocuronium Induced Neuromuscular Block - A Randomised Electrophysiology Study
調査の概要
詳細な説明
In a previous study pre-treatment with intravenous MgSO4 60 mg kg-1 was not shown to have any impact on the onset of action of rocuronium [Kussmann et al, 1997]. Yet, in that study, MgSO4 was injected as a bolus after induction of anaesthesia, one minute only before the injection of the neuromuscular blocking agent. We suppose that magnesium needs some time to penetrate the neuromuscular endplate and to shift the Mg/Ca ratio in favor of magnesium. Thus, the particular design of the previous study may explain why magnesium had no scope to enhance the speed of onset of action of rocuronium.
The aim of our study is to investigate whether an optimised pre-treatment with magnesium (short infusion rather than bolus injection; reasonable delay between administration of magnesium and subsequent injection of the neuromuscular blocking agent) enhances the speed of onset of a standard intubation dose of rocuronium.
Preanaesthetic preparation
- Solid food and liquid intake will not be allowed for a minimum of six hours before induction
- Patients will be premedicated with 7.5 mg oral midazolam 45 min prior to induction
- Standard monitoring will consist of: ECG, SaO2, ETCO2, non-invasive blood pressure, rectal or oesophageal T°
Study drug administration
- Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group. The infusion will be given with an Infusomat during 15 minutes.
Induction and maintenance of anaesthesia
- At the end of the study drug infusion, and after a preoxygenation period of three minutes, anaesthesia will be induced with sufentanil 0.2µg kg-1 and propofol, using a Target Controlled Infusion (TCI) system (Base Primea, Fresenius-Vial, Brezins, France) and the pharmacokinetic model of Schnider et al [Schnider et al, 1999]. The initial effect site concentration will be 4 µg ml-1.
- Maintenance of anaesthesia will be with a propofol effect site
Neuromuscular monitoring
- Neuromuscular function will be monitored using the TOF Watch® SX (NV Organon) and TOF nerve stimulation. The guidelines for good clinical research practice in pharmacodynamic studies of NMBAs will be followed.
- The ulnar nerve is stimulated through surface electrodes, and the adductor pollicis muscle response is measured.
- After the stabilisation period, rocuronium 0.6 mg kg-1 (2 x ED95) will be injected intravenously during 5 seconds.
- The trachea will be intubated after a 95% depression of the first twitch
5.1. Neuromuscular measurements
- Onset time = time from beginning of injection of rocuronium until a 95% depression of the first twitch (T1).
- Duration 25% = time from beginning of injection of rocuronium until 25% T1 recovery.
- Recovery index T25-75 = time between 25% T1 recovery and 75% T1 recovery.
- Clinical recovery T25 - 0.9 = time between 25% T1 recovery and TOF ratio (T1/T4) of 0.9 (corresponding to safe extubation condition).
5.2. Haemodynamics
- Blood pressure
- Heart rate These measurements will be done before (baseline), and at 5-minute intervals during the study drug infusion. Before and immediately after tracheal intubation, haemodynamic measurements will be repeated.
5.3. Adverse events, safety
- Any minor adverse event (no need for intervention) or major adverse events will be recorded.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Canton of Geneva
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Geneva、Canton of Geneva、スイス、1211
- University Hospital of Geneva, Anesthesia Department
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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:
- American Society of Anaesthesiology (ASA) status I or II
- Adults, aged 18 years to 60 years
- Scheduled for elective surgery lasting longer than 120 min without need for continuous curarisation
Exclusion Criteria:
- A history of allergy or hypersensitivity to rocuronium
- Neuromuscular disease
- Preoperative medications known to influence neuromuscular function (for instance, certain antibiotics and anticonvulsants)
- Electrolyte abnormalities
- Hepatic or renal insufficiency
- Patients with a body mass index <19 or >28 kg m2
- Pregnant or breastfeeding women
- Expected difficult intubation or mask ventilation
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
- 主な目的:処理
- 割り当て:ランダム化
- 介入モデル:単一グループの割り当て
- マスキング:4倍
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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プラセボコンパレーター:生理食塩水
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Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group and 1 ml per kg physiological saline.
The infusion will be given with during 15 minutes.
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アクティブコンパレータ:Magnesium sulphate
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Intravenous infusion of the study solution, 1 ml per kg bodyweight, corresponding to MgSO4 60 mg kg-1 in the magnesium group.
The infusion will be given during 15 minutes.
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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 |
|---|---|---|
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To study whether a pre-treatment with MgSO4, 60 mg kg-1, administered as an intravenous infusion 15 minutes prior to induction enhances the speed of onset of a standard intubation dose of rocuronium
時間枠:1 to 5 minutes
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Onset time ist the time in seconds from start of injection of rocuronium until 95% depression of the first twitch (T1) of the Train of four (TOF)
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1 to 5 minutes
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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To study whether, and to what extent, pre-treatment with MgSO4 prolongs recovery characteristics of the neuromuscular block that is induced by rocuronium
時間枠:minutes to hours
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minutes to hours
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To study possible haemodynamic effects of pre-treatment with MgSO4.
時間枠:hours
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hours
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協力者と研究者
捜査官
- 主任研究者:Christoph A Czarnetzki, MD, MBA、University Hospital of Geneva, Anesthesia Department
- スタディチェア:Martin Tramer, MD, PhD、University Hospital of Geneva, Anesthesia Department
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
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CER 05-055
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