与七氟醚和全凭静脉麻醉相比，氙气麻醉用于冠状动脉搭桥手术对术后心肌肌钙蛋白释放的影响：一项国际多中心3期单盲随机非劣效性试验
Effect of Xenon Anesthesia Compared to Sevoflurane and Total Intravenous Anesthesia for Coronary Artery Bypass Graft Surgery on Postoperative Cardiac Troponin Release: An International, Multicenter, Phase 3, Single-blinded, Randomized Noninferiority Trial.
作者信息
Hofland Jan, Ouattara Alexandre, Fellahi Jean-Luc, Gruenewald Matthias, Hazebroucq Jean, Ecoffey Claude, Joseph Pierre, Heringlake Matthias, Steib Annick, Coburn Mark, Amour Julien, Rozec Bertrand, Liefde Inge de, Meybohm Patrick, Preckel Benedikt, Hanouz Jean-Luc, Tritapepe Luigi, Tonner Peter, Benhaoua Hamina, Roesner Jan Patrick, Bein Berthold, Hanouz Luc, Tenbrinck Rob, Bogers Ad J J C, Mik Bert G, Coiffic Alain, Renner Jochen, Steinfath Markus, Francksen Helga, Broch Ole, Haneya Assad, Schaller Manuella, Guinet Patrick, Daviet Lauren, Brianchon Corinne, Rosier Sebastien, Lehot Jean-Jacques, Paarmann Hauke, Schön Julika, Hanke Thorsten, Ettel Joachym, Olsson Silke, Klotz Stefan, Samet Amir, Laurinenas Giedrius, Thibaud Adrien, Cristinar Mircea, Collanges Olivier, Levy François, Rossaint Rolf, Stevanovic Ana, Schaelte Gereon, Stoppe Christian, Hamou Nora Ait, Hariri Sarah, Quessard Astrid, Carillion Aude, Morin Hélène, Silleran Jacqueline, Robert David, Crouzet Anne-Sophie, Zacharowski Kai, Reyher Christian, Iken Sonja, Weber Nina C, Hollmann Marcus, Eberl Susanne, Carriero Giovanni, Collacchi Daria, Di Persio Alessandra, Fourcade Olivier, Bergt Stefan, Alms Angela
机构信息
From the Sector Cardiothoracic Anesthesiology, Thorax Centre, Rotterdam, The Netherlands (J. Hofland, I.d.L.); Service d'Anesthésie-Réanimation II, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France (A.O.); Louis Pradel University Hospital, Lyon, France and Department of Anesthesiology and Intensive Care Medicine and Inserm U1060, Faculty of Medicine, Claude Bernard Lyon 1 University, Lyon, France (J.-L.F.); Department of Anaesthesiology and Intensive Care Medicine, University Hospital Schleswig-Holstein, Campus Kiel, Kiel, Germany (M.G., B.B.); Air Liquide Santé International, Paris-Saclay Research Center, Jouy-en-Josas, France (J. Hazebroucq); Department of Anesthesia, Hôpital Pontchaillou, Centre Hospitalier Universitaire de Rennes, Rennes, France (C.E.); Department of Anesthesia and Intensive Care, Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Bron, France (P.J.); Department of Anesthesiology and Intensive Care Medicine, University of Lübeck, Lübeck, Germany (M.H.); Service d'Anesthésie Réanimation Chirurgicale, Nouvel Hôpital Civil, Centre Hospitalier Régional Universitaire de Strasbourg, Strasbourg, France (A.S.); Department of Anesthesiology, University Hospital RWTH Aachen, Aachen, Germany (M.C.); Department of Anesthesia and Intensive Care, Institut de Cardiologie - Chirurgie Cardiaque, Hôpital Pitié Salpetrière, Paris, France (J.A.); Service d'Anesthésie et Réanimation Chirurgicale, Hôpital G&R Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes, France (B.R.); Clinic of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt am Main, Frankfurt am Main, Germany (P.M.); Department of Anesthesiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands (B.P.); Service d'Anesthésie et Réanimation Chirurgicale, Centre Hospitalier Universitaire de Caen, Caen, France (J.-L.H.); Department of Anesthesia and Intensive Care, Policlinico "Umberto I," "La Sapienza," University of Rome, Rome, Italy (L.T.); Department of Anesthesiology and Intensive Care, Klinikum Links der Weser gGmbH, Bremen, Germany (P.T.); Chirurgie Cardiovasculaire - Service de Réanimation, Centre Hospitalier Universitaire de Toulouse, Hospitalier de Rangueil, Toulouse, France (H.B.); and Clinic for Anesthesia and Critical Care Medicine, University Hospital Rostock, Rostock, Germany (J.P.R). Service d'Anesthésie et Réanimation Chirurgicale, Centre Hospitalier Universitaire de Caen, Caen, France Departments of Anesthesiology and Cardiothoracic Surgery, Thorax Centre, Rotterdam, The Netherlands Departments of Anesthesiology and Cardiothoracic Surgery, Thorax Centre, Rotterdam, The Netherlands Departments of Anesthesiology and Cardiothoracic Surgery, Thorax Centre, Rotterdam, The Netherlands Service d'Anesthésie-Réanimation II, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France Universitäts Klinikum Schleswig-Holstein, Klinik für Anästhesiologie und Operative Intensivmedizin, Campus Kiel, Kiel, Germany Universitäts Klinikum Schleswig-Holstein, Klinik für Anästhesiologie und Operative Intensivmedizin, Campus Kiel, Kiel, Germany Universitäts Klinikum Schleswig-Holstein, Klinik für Anästhesiologie und Operative Intensivmedizin, Campus Kiel, Kiel, Germany Universitäts Klinikum Schleswig-Holstein, Klinik für Anästhesiologie und Operative Intensivmedizin, Campus Kiel, Kiel, Germany Universitäts Klinikum Schleswig-Holstein, Klinik für Anästhesiologie und Operative Intensivmedizin, Campus Kiel, Kiel, Germany Air Liquide Santé International, Jouy-en-Josas, France Department of Anesthesia, Hôpital Pontchaillou, Rennes, France Department of Anesthesia, Hôpital Pontchaillou, Rennes, France Department of Anesthesia, Hôpital Pontchaillou, Rennes, France Department of Anesthesia, Hôpital Pontchaillou, Rennes, France Department of Anesthesia and Intensive Care, Hôpital Cardiovasculaire et Pneumologique Louis Pradel, Bron, France Department of Anesthesiology and Intensive Care Medicine, University of Lübeck, Lübeck, Germany Department of Anesthesiology and Intensive Care Medicine, University of Lübeck, Lübeck, Germany Department of Anesthesiology and Intensive Care Medicine, University of Lübeck, Lübeck, Germany Department of Anesthesiology and Intensive Care Medicine, University of Lübeck, Lübeck, Germany Department of Anesthesiology and Intensive Care Medicine, University of Lübeck, Lübeck, Germany Department of Cardiac and Thoracic Vascular Surgery, University of Lübeck, Lübeck, Germany Service d'Anesthésie Réanimation Chirurgicale, Hôpitaux Universitaire de Strasbourg, Strasbourg, France Service d'Anesthésie Réanimation Chirurgicale, Hôpitaux Universitaire de Strasbourg, Strasbourg, France Service d'Anesthésie Réanimation Chirurgicale, Hôpitaux Universitaire de Strasbourg, Strasbourg, France Service d'Anesthésie Réanimation Chirurgicale, Hôpitaux Universitaire de Strasbourg, Strasbourg, France Service d'Anesthésie Réanimation Chirurgicale, Hôpitaux Universitaire de Strasbourg, Strasbourg, France Service d'Anesthésie Réanimation Chirurgicale, Hôpitaux Universitaire de Strasbourg, Strasbourg, France Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany Department of Anaesthesiology, University Hospital RWTH Aachen, Aachen, Germany Department of Anesthesia and Intensive Care, Institut de Cardiologie - Chirurgie Cardiaque, Hôpital Pitié Salpetrière, Paris, France Department of Anesthesia and Intensive Care, Institut de Cardiologie - Chirurgie Cardiaque, Hôpital Pitié Salpetrière, Paris, France Department of Anesthesia and Intensive Care, Institut de Cardiologie - Chirurgie Cardiaque, Hôpital Pitié Salpetrière, Paris, France Department of Anesthesia and Intensive Care, Institut de Cardiologie - Chirurgie Cardiaque, Hôpital Pitié Salpetrière, Paris, France Service d'Anesthésie et Réanimation Chirurgicale, Hôpital G&R Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes, France Service d'Anesthésie et Réanimation Chirurgicale, Hôpital G&R Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes, France Service d'Anesthésie et Réanimation Chirurgicale, Hôpital G&R Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes, France Service d'Anesthésie et Réanimation Chirurgicale, Hôpital G&R Laënnec, Centre Hospitalier Universitaire de Nantes, Nantes, France Clinic of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt am Main, Frankfurt am Main, Germany Clinic of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt am Main, Frankfurt am Main, Germany Clinic of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Frankfurt am Main, Frankfurt am Main, Germany Department of Anesthesiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Department of Anesthesiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Department of Anesthesiology, Academic Medical Center, University of Amsterdam, Amsterdam, The Netherlands Department of Anesthesia and Intensive Care, Policlinico "Umberto I," "La Sapienza," University of Rome, Rome, Italy Department of Anesthesia and Intensive Care, Policlinico "Umberto I," "La Sapienza," University of Rome, Rome, Italy Department of Anesthesia and Intensive Care, Policlinico "Umberto I," "La Sapienza," University of Rome, Rome, Italy Chirurgie Cardiovasculaire - Service de Réanimation, Centre Hospitalier Regional Universitaire, Hospitalier de Rangueil, Toulouse, France Clinic for Anesthesia and Critical Care Medicine, University Hospital of Rostock, Rostock, Germany Clinic for Anesthesia and Critical Care Medicine, University Hospital of Rostock, Rostock, Germany.
出版信息
Anesthesiology. 2017 Dec;127(6):918-933. doi: 10.1097/ALN.0000000000001873.
BACKGROUND
Ischemic myocardial damage accompanying coronary artery bypass graft surgery remains a clinical challenge. We investigated whether xenon anesthesia could limit myocardial damage in coronary artery bypass graft surgery patients, as has been reported for animal ischemia models.
METHODS
In 17 university hospitals in France, Germany, Italy, and The Netherlands, low-risk elective, on-pump coronary artery bypass graft surgery patients were randomized to receive xenon, sevoflurane, or propofol-based total intravenous anesthesia for anesthesia maintenance. The primary outcome was the cardiac troponin I concentration in the blood 24 h postsurgery. The noninferiority margin for the mean difference in cardiac troponin I release between the xenon and sevoflurane groups was less than 0.15 ng/ml. Secondary outcomes were the safety and feasibility of xenon anesthesia.
RESULTS
The first patient included at each center received xenon anesthesia for practical reasons. For all other patients, anesthesia maintenance was randomized (intention-to-treat: n = 492; per-protocol/without major protocol deviation: n = 446). Median 24-h postoperative cardiac troponin I concentrations (ng/ml [interquartile range]) were 1.14 [0.76 to 2.10] with xenon, 1.30 [0.78 to 2.67] with sevoflurane, and 1.48 [0.94 to 2.78] with total intravenous anesthesia [per-protocol]). The mean difference in cardiac troponin I release between xenon and sevoflurane was -0.09 ng/ml (95% CI, -0.30 to 0.11; per-protocol: P = 0.02). Postoperative cardiac troponin I release was significantly less with xenon than with total intravenous anesthesia (intention-to-treat: P = 0.05; per-protocol: P = 0.02). Perioperative variables and postoperative outcomes were comparable across all groups, with no safety concerns.
CONCLUSIONS
In postoperative cardiac troponin I release, xenon was noninferior to sevoflurane in low-risk, on-pump coronary artery bypass graft surgery patients. Only with xenon was cardiac troponin I release less than with total intravenous anesthesia. Xenon anesthesia appeared safe and feasible.
背景
冠状动脉搭桥手术伴随的缺血性心肌损伤仍然是一个临床挑战。我们研究了氙气麻醉是否能像在动物缺血模型中所报道的那样，限制冠状动脉搭桥手术患者的心肌损伤。
方法
在法国、德国、意大利和荷兰的17家大学医院，将低风险择期、体外循环冠状动脉搭桥手术患者随机分组，在麻醉维持阶段分别接受氙气、七氟醚或丙泊酚全静脉麻醉。主要结局是术后24小时血液中的心肌肌钙蛋白I浓度。氙气组和七氟醚组之间心肌肌钙蛋白I释放量的平均差异的非劣效界值小于0.15 ng/ml。次要结局是氙气麻醉的安全性和可行性。
结果
由于实际原因，每个中心纳入的首例患者接受了氙气麻醉。对于所有其他患者，麻醉维持是随机分配的（意向性分析：n = 492；符合方案/无重大方案偏离：n = 446）。术后24小时心肌肌钙蛋白I浓度中位数（ng/ml[四分位间距]），氙气组为1.14[0.76至2.10]，七氟醚组为1.30[0.78至2.67]，全静脉麻醉组为1.48[0.94至2.78][符合方案]。氙气组和七氟醚组之间心肌肌钙蛋白I释放量的平均差异为-0.09 ng/ml（95%CI，-0.30至0.11；符合方案：P = 0.02）。氙气组术后心肌肌钙蛋白I释放量显著低于全静脉麻醉组（意向性分析：P = 0.05；符合方案：P =
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