Influence of Intraoperative Analgesia on the Postoperative Morphine Consumption
Influence of Intraoperative Analgesia (Sufentanil Administered According to the Usual Criteria or Remifentanil Administered by a Closed-loop System Using Bispectral Index as the Controller) on the Postoperative Morphine Consumption
Unlike longer acting opiates (sufentanil), remifentanil may provoke postoperative hyperalgesia. We have developed two automated bispectral index - guided drug delivery systems: one for propofol administration, the other for combined propofol and remifentanil administration. Both systems achieve the same objective: similar level of anesthesia indicated by bispectral index levels between 40 to 60. We make the assumption that this method of automated remifentanil administration may avoid postoperative hyperalgesia. Patients scheduled for abdominal surgery will be divided into two groups:
- in one group, patients will receive automatically delivered propofol and manually delivered sufentanil according to the usual criteria,
- in the other group, patients will receive propofol and remifentanil both automatically administered.
Assessment of postoperative hyperalgesia will be primarily based on morphine consumption (patient controlled analgesia) and detection of cutaneous hyperalgesia areas.
調査の概要
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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Suresnes、フランス、92150
- Hopital 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:
- Patients scheduled for an abdominal surgery
Exclusion Criteria:
- Age less than 18 years,
- Pregnant women,
- Allergy to propofol, sufentanil, remifentanil, morphine, muscle relaxant, or to a component,
- Hypersensibility to sufentanil, remifentanil or to a derivate of fentanyl,
- Inflammatory bowel disease,
- Chronic pain,
- Patients receiving a psychotropic treatment or a a morphine agonist-antagonist,
- Alcoholic patients and patients taking opiates,
- History of neurological disorders or central brain lesion, of severe respiratory insufficiency, of hepatic insufficiency,
- 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：基礎科学
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：1
Patients will receive propofol and remifentanil automatically administered (closed-loop administration using bispectral index as the single input for the controller).
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closed-loop administration using bispectral index as the single input for the controller.
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アクティブコンパレータ：2
Patients will receive propofol automatically administered (closed-loop administration using bispectral index as the single input for the controller) and sufentanil according to usual criteria
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dosage according to usual criteria
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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 |
時間枠 |
|---|---|
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Dose of morphine administered during the postoperative period (patient controlled analgesia)
時間枠：48 postoperative hours
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48 postoperative hours
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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postoperative pain scores
時間枠：48 postoperative hours
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48 postoperative hours
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postoperative hyperalgesia
時間枠：up to 5th to 7th postoperative days
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up to 5th to 7th postoperative days
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nausea vomiting
時間枠：48 postoperative hours
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48 postoperative hours
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協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Liu N, Chazot T, Genty A, Landais A, Restoux A, McGee K, Laloe PA, Trillat B, Barvais L, Fischler M. Titration of propofol for anesthetic induction and maintenance guided by the bispectral index: closed-loop versus manual control: a prospective, randomized, multicenter study. Anesthesiology. 2006 Apr;104(4):686-95. doi: 10.1097/00000542-200604000-00012.
- Joly V, Richebe P, Guignard B, Fletcher D, Maurette P, Sessler DI, Chauvin M. Remifentanil-induced postoperative hyperalgesia and its prevention with small-dose ketamine. Anesthesiology. 2005 Jul;103(1):147-55. doi: 10.1097/00000542-200507000-00022.
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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