1.Sugammadex: clinical development and practical use.
Thomas FUCHS-BUDER ; Claude MEISTELMAN ; Julien RAFT
Korean Journal of Anesthesiology 2013;65(6):495-500
Sugammadex is belonging to a new class of drugs: the selective relaxant binding agents. Sugammadex can reverse residual paralysis by encapsulating free circulating non depolarizing muscle relaxants. The mains advantages of sugammadex when compared with conventional anticholinesterase agents are a much faster recovery time and the unique ability, for the first time, to reverse rapidly and efficiently deep levels of neuromuscular blockade. However it only works for reversal of rocuronium or vecuronium-induced neuromuscular blockade. When administered 3 min after rocuronium the use of a large dose (16 mg/kg) can even reverse rocuronium significantly faster than the spontaneous recovery after succinylcholine.
Cholinesterase Inhibitors
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Cyclodextrins
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Neostigmine
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Neuromuscular Blockade
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Neuromuscular Depolarizing Agents
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Paralysis
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Succinylcholine
2.Biological evaluation of the effect of sugammadex on hemostasis and bleeding.
Julien RAFT ; Philippe GUERCI ; Valentin HARTER ; Thomas FUCHS-BUDER ; Claude MEISTELMAN
Korean Journal of Anesthesiology 2015;68(1):17-21
BACKGROUND: Notification of sugammadex has been supplemented with a section on hemostasis, including a longer clotting time in the first minutes following injection, without any documented clinical consequences. The objective of this observational study was to analyze the effects of sugammadex administration on routine coagulation tests and bleeding in the clinical setting. METHODS: After Institutional Review Board approval, a prospective observational study was conducted between January and December 2011. Adult patients scheduled for laparotomies were analyzed in groups according to the type of reversal (without sugammadex versus 2 or 4 mg/kg sugammadex). There were no changes in our current clinical practice. Blood samples drawn from these patients were standardized at the same time and tested using the same daily calibrated machine. The endpoint was a comparison of the activated partial thromboplastin time (aPTT), prothrombin time (PT), hemoglobin (Hb) level and hematocrit (Ht), immediately before sugammadex administration (H0) and 1 h after neuromuscular block reversal (H1). RESULTS: One hundred and forty-two patients in three groups were included as follows: 11 in the "without sugammadex" group, 64 in the "2 mg/kg sugammadex" group and 67 in the "4 mg/kg sugammadex" group. Results did not differ significantly among the groups. CONCLUSIONS: In this prospective observational study, the use of 2 and 4 mg/kg sugammadex was not associated with a longer clotting time or decreased hemoglobin concentrations. Future prospective investigations should study patients receiving 16 mg/kg sugammadex and/or with abnormal coagulation tests.
Adult
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Ethics Committees, Research
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Hematocrit
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Hemorrhage*
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Hemostasis*
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Humans
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Laparotomy
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Neuromuscular Blockade
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Observational Study
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Partial Thromboplastin Time
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Prospective Studies
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Prothrombin Time
3.Guidelines on muscle relaxants and reversal in anaesthesia
Beno?t PLAUD ; Christophe BAILLARD ; Jean-Louis BOURGAIN ; Ga?lle BOUROCHE ; Laetitia DESPLANQUE ; Jean-Michel DEVYS ; Dominique FLETCHER ; Thomas FUCHS-BUDER ; Gilles LEBUFFE ; Claude MEISTELMAN ; Cyrus MOTAMED ; Julien RAFT ; Frédérique SERVIN ; Didier SIRIEIX ; Karem SLIM ; Lionel VELLY ; Franck VERDONK ; Bertrand DEBAENE
Chinese Journal of Anesthesiology 2022;42(7):771-793
Objectives:To provide an update to the 1999 French guidelines on " Muscle relaxants and reversal in anaesthesia" , a consensus committee of sixteen experts was convened.A formal policy of declaration and monitoring of conflicts of interest (COI) was developed at the outset of the process and enforced throughout.The entire guidelines process was conducted independently of any industrial funding (i.e.pharmaceutical, medical devices). The authors were required to follow the rules of the Grading of Recommendations, Assessment, Development and Evaluation (GRADE ?) system to assess the quality of the evidence on which the recommendations were based.The potential drawbacks of making strong recommendations based on low-quality evidence were stressed.Few of the recommendations remained ungraded. Methods:The panel focused on eight questions: (1) In the absence of difficult mask ventilation criteria, is it necessary to check the possibility of ventilation via a facemask before muscle relaxant injection? Is it necessary to use muscle relaxants to facilitate facemask ventilation? (2) Is the use of muscle relaxants necessary to facilitate tracheal intubation? (3) Is the use of muscle relaxants necessary to facilitate the insertion of a supraglottic device and management of related complications? (4) Is it necessary to monitor neuromuscular blockade for airway management? (5) Is the use of muscle relaxants necessary to facilitate interventional procedures, and if so, which procedures? (6) Is intraoperative monitoring of neuromuscular blockade necessary? (7) What are the strategies for preventing and treating residual neuromuscular blockade? (8) What are the indications and precautions for use of both muscle relaxants and reversal agents in special populations (e.g.electroconvulsive therapy, obese patients, children, neuromuscular diseases, renal/hepatic failure, elderly patients)? All questions were formulated using the Population, Intervention, Comparison and Outcome (PICO) model for clinical questions and evidence profiles were generated.The results of the literature analysis and the recommendations were then assessed using the GRADE ? system. Results:The summaries prepared by the SFAR Guideline panel resulted in thirty-one recommendations on muscle relaxants and reversal agents in anaesthesia.Of these recommendations, eleven have a high level of evidence (GRADE 1±) while twenty have a low level of evidence (GRADE 2±). No recommendations could be provided using the GRADE ? system for five of the questions, and for two of these questions expert opinions were given.After two rounds of discussion and an amendment, a strong agreement was reached for all the recommendations. Conclusion:Substantial agreement exists among experts regarding many strong recommendations for the improvement of practice concerning the use of muscle relaxants and reversal agents during anaesthesia.In particular, the French Society of Anaesthesia and Intensive Care (SFAR) recommends the use of a device to monitor neuromuscular blockade throughout anaesthesia.
4.Peri-operative management of neuromuscular blockade: a guideline from the European Society of Anaesthesiology and Intensive Care
Thomas FUCHS-BUDER ; S. Carolina ROMERO ; Heidrun LEWALD ; Massimo LAMPERTI ; Arash AFSHARI ; Ana-Marjia HRISTOVSKA ; Denis SCHMARTZ ; Jochen HINKELBEIN ; Dan LONGROIS ; Maria POPP ; De Boer Hans D. ; Massimiliano SORBELLO ; Radmilo JANKOVIC ; Peter KRANKE
Chinese Journal of Anesthesiology 2024;44(6):641-656
Recent data indicated a high incidence of inappropriate management of neuromuscular block, with a high rate of residual paralysis and relaxant-associated postoperative complications. These data are alarming in that the available neuromuscular monitoring, as well as myorelaxants and their antagonists basically allow well tolerated management of neuromuscular blockade. In this first European Society of Anaesthesiology and Intensive Care (ESAIC) guideline on peri-operative management of neuromuscular block, we aim to present aggregated and evidence-based recommendations to assist clinicians provide best medical care and ensure patient safety. We identified three main clinical questions: Are myorelaxants necessary to facilitate tracheal intubation in adults? Does the intensity of neuromuscular blockade influence a patient′s outcome in abdominal surgery? What are the strategies for the diagnosis and treatment of residual paralysis? On the basis of this, PICO (patient, intervention, comparator, outcome) questions were derived that guided a structured literature search. A stepwise approach was used to reduce the number of trials of the initial research ( n=24 000) to the finally relevant clinical studies ( n=88). GRADE methodology (Grading of Recommendations, Assessment, Development and Evaluation) was used for formulating the recommendations based on the findings of the included studies in conjunction with their methodological quality. A two-step Delphi process was used to determine the agreement of the panel members with the recommendations: R1 We recommend using a muscle relaxant to facilitate tracheal intubation (1A). R2 We recommend the use of muscle relaxants to reduce pharyngeal and/or laryngeal injury following endotracheal intubation (1C). R3 We recommend the use of a fast-acting muscle relaxant for rapid sequence induction intubation (RSII) such as succinylcholine 1 mg/kg or rocuronium 0.9 to 1.2 mg/kg (1B). R4 We recommend deepening neuromuscular blockade if surgical conditions need to be improved (1B). R5 There is insufficient evidence to recommend deep neuromuscular blockade in general to reduce postoperative pain or decrease the incidence of peri-operative complications (2C). R6 We recommend the use of ulnar nerve stimulation and quantitative neuromuscular monitoring at the adductor pollicis muscle to exclude residual paralysis (1B). R7 We recommend using sugammadex to antagonise deep, moderate and shallow neuromuscular blockade induced by aminosteroidal agents (rocuronium, vecuronium) (1A). R8 We recommend advanced spontaneous recovery (i. e. TOF ratio>0.2) before starting neostigmine-based reversal and to continue quantitative monitoring of neuromuscular blockade until a TOF ratio of more than 0.9 has been attained (1C).