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DOI 10.1097/aln.0000000000001873

Медицинская библиотека · Anesthesiology · 2017

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.

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, Xenon-CABG Study Group

Клиническое исследование III фазыСравнительное исследованиеСтатьяМногоцентровое исследованиеРандомизированное исследованиеПеревод в очереди

Аннотация

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.

Для цитирования: 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, Xenon-CABG Study Group. 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.. Anesthesiology. 2017. DOI: 10.1097/aln.0000000000001873.

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