Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy
Target-controlled Infusion of Propofol and Remifentanil During General Anaesthesia Guided by Entropy of the Electroencephalogram: Comparison Between Manual Perfusion and Automated Perfusion
調査の概要
詳細な説明
Several monitors are currently proposed to evaluate the depth of hypnosis. Among them, Bispectral Index (BIS) is a well known and widely used parameter derived from the patient's electroencephalograph (EEG). A closed-loop anesthesia system can be built using BIS as the control variable, a proportional-integral-differential control algorithm, a propofol and a remifentanil target-controlled infusion systems as the control actuators Preliminary results show that this system can be used during surgery.
Spectral entropy relies on the extent of disorder in both EEG and electromyography (EMG) signals and returns 2 values: State Entropy (SE) and Response Entropy. SE is computed over the frequency range of 0.8-32 Hz and reflects the level of hypnosis while Response Entropy is computed over the frequency range of 0.8-47 Hz and reflects also EMG activity. BIS and SE are dimensionless numbers scaled from 100 to 0 for BIS and from 91 to 0 for SE. We hypothesized that SE can be used as the control variable. In preparation for a large multi-center control trial, we propose a prospective randomized study to evaluate the effectiveness of such a closed-loop anesthesia system. Two groups of patients are compared: one in which propofol and remifentanil are administered by the anesthesiologist using target-controlled infusion systems, and one in which propofol and remifentanil are administered automatically by the combined closed-loop anesthesia system. In both groups, the goal is to maintain SE between 40 and 60, the recommended range during anesthesia by the manufacturer. We expect the combined closed-loop anesthesia system group to do similar or better.
研究の種類
入学
段階
- フェーズ 4
連絡先と場所
研究場所
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Clichy、フランス、92110
- Dept of Anesthesia and Intensive Care, Hôpital Beaujon
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Suresnes、フランス、92150
- Dept of Anesthesiology, Hôpital Foch
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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 Anesthesiologists physical status 1-3,
- surgery under general anesthesia using relaxant agent,
- surgery lasting more than one hour
Exclusion Criteria:
- pregnant women,
- indication for rapid sequence induction,
- anticipation of difficult intubation,
- allergy to propofol or remifentanil,
- neurological or muscular disorder,
- combination of general anesthesia and of regional anesthesia,
- emergency surgery
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:並列代入
- マスキング:なし(オープンラベル)
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 |
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Global score (calculated parameter which depicts the performance of the system, i.e. its capacity to maintain BIS in the desired range)
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二次結果の測定
結果測定 |
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consumption of propofol and remifentanil during the induction and the maintenance of the anaesthesia
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number of modifications of target of propofol and remifentanil
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number of episodes of hemodynamic anomalies having required a treatment
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intraoperative volume loading and transfusion
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extubation time, explicit memorisation
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dysfunctions of each system
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協力者と研究者
スポンサー
捜査官
- 主任研究者:Marc Fischler, MD、Hôpital Foch
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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Closed-loop anesthesia systemの臨床試験
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Biotronik SE & Co. KG完了
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Biotronik SE & Co. KG完了心臓ペーシング、人工ドイツ, イスラエル, 香港, オーストリア, チェコ共和国, オーストラリア, ブラジル, カナダ, スロバキア, スペイン