RESUMO
BACKGROUND AND OBJECTIVE: Sugammadex reverses neuromuscular blockade induced by aminosteroid agents by encapsulating these agents. The objective of this study was to compare the efficacy and safety of sugammadex to reverse a rocuronium-induced neuromuscular blockade in long-duration surgery in association with inhaled or intravenous anesthesia. PATIENTS AND METHODS: We performed a randomized, double-blind, multicenter trial of 20 ASA 1-3 patients aged between 18 and 69 years and scheduled for elective surgery lasting at least 120 minutes. Anesthesia was induced with remifentanil and rocuronium at a dosage of 0.6 mg x kg(-1), and neuromuscular function was monitored by means of acceleromyography. After randomization, anesthesia was maintained with sevoflurane or with propofol for total intravenous anesthesia. Patients in both groups also received an infusion of remifentanil for analgesia and rocuronium to maintain a block of greater than 90%. After surgery, sugammadex was administered at a dosage of 2 mg x kg(-1) on reappearance of the second train-of-four (TOF) twitch (T2) and the times until recovery of T4/T1 ratios of 0.7, 0.8, and 0.9 (main endpoints). Mean arterial pressure and heart rate were recorded at baseline and after 2, 5, 10, and 30 minutes (secondary outcome measures). RESULTS: Although less rocuronium was consumed in the sevoflurane group than in the propofol group and the time between the start of sugammadex administration until recovery of a TOF ratio of 0.9 was shorter for the sevoflurane group than for propofol group (mean [SD], 1.46 [0.30] minutes and 1.89 [0.62] minutes, respectively), these differences were not significant. No signs of recurarization or associated adverse effects were observed. CONCLUSIONS: Sugammadex effectively and safely reverses a rocuronium-induced neuromuscular blockade in less than 2 minutes in long-duration surgery performed under both inhaled and intravenous anesthesia. The interaction of neuromuscular blocking agents with sevoflurane appears not to affect the reversal time of sugammadex in such operations.
Assuntos
Androstanóis/efeitos adversos , Anestesia por Inalação , Anestesia Intravenosa , Bloqueio Neuromuscular/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , gama-Ciclodextrinas/uso terapêutico , Adolescente , Adulto , Idoso , Androstanóis/administração & dosagem , Androstanóis/farmacologia , Período de Recuperação da Anestesia , Anestésicos Inalatórios/administração & dosagem , Anestésicos Inalatórios/farmacologia , Anestésicos Intravenosos/administração & dosagem , Anestésicos Intravenosos/farmacologia , Pressão Sanguínea/efeitos dos fármacos , Método Duplo-Cego , Interações Medicamentosas , Procedimentos Cirúrgicos Eletivos , Feminino , Frequência Cardíaca/efeitos dos fármacos , Humanos , Masculino , Éteres Metílicos/administração & dosagem , Éteres Metílicos/farmacologia , Pessoa de Meia-Idade , Fármacos Neuromusculares não Despolarizantes/administração & dosagem , Fármacos Neuromusculares não Despolarizantes/farmacologia , Piperidinas/administração & dosagem , Piperidinas/farmacologia , Propofol/administração & dosagem , Propofol/farmacologia , Estudos Prospectivos , Remifentanil , Rocurônio , Sevoflurano , Sugammadex , Adulto Jovem , gama-Ciclodextrinas/administração & dosagem , gama-Ciclodextrinas/farmacologiaRESUMO
INTRODUCTION: Neuromuscular blockade enables airway management, ventilation and surgical procedures. However there is no national consensus on its routine clinical use. The objective was to establish the degree of agreement among anaesthesiologists and general surgeons on the clinical use of neuromuscular blockade in order to make recommendations to improve its use during surgical procedures. METHODS: Multidisciplinary consensus study in Spain. Anaesthesiologists experts in neuromuscular blockade management (n=65) and general surgeons (n=36) were included. Delphi methodology was selected. A survey with 17 final questions developed by a dedicated scientific committee was designed. The experts answered the successive questions in two waves. The survey included questions on: type of surgery, type of patient, benefits/harm during and after surgery, impact of objective neuromuscular monitoring and use of reversal drugs, viability of a multidisciplinary and efficient approach to the whole surgical procedure, focussing on the level of neuromuscular blockade. RESULTS: Five recommendations were agreed: 1) deep neuromuscular blockade is very appropriate for abdominal surgery (degree of agreement 94.1%), 2) and in obese patients (76.2%); 3) deep neuromuscular blockade maintenance until end of surgery might be beneficial in terms of clinical aspects, such as as immobility or better surgical access (86.1 to 72.3%); 4) quantitative monitoring and reversal drugs availability is recommended (89.1%); finally 5) anaesthesiologists/surgeons joint protocols are recommended. CONCLUSIONS: Collaboration among anaesthesiologists and surgeons has enabled some general recommendations to be established on deep neuromuscular blockade use during abdominal surgery.
Assuntos
Bloqueio Neuromuscular/métodos , Adulto , Anestesiologia , Contraindicações de Procedimentos , Recuperação Demorada da Anestesia/prevenção & controle , Técnica Delphi , Prova Pericial , Feminino , Cirurgia Geral , Humanos , Consciência no Peroperatório/prevenção & controle , Masculino , Pessoa de Meia-Idade , Bloqueio Neuromuscular/efeitos adversos , Bloqueio Neuromuscular/normas , Bloqueadores Neuromusculares/administração & dosagem , Bloqueadores Neuromusculares/efeitos adversos , Monitoração Neuromuscular , Médicos/psicologiaRESUMO
OBJECTIVE: The overall objective of the study is to determine the ability of TOF-Cuff device (blood-pressure modified cuff, including stimulation electrodes) to monitor with the same device the non-invasive blood pressure (NIBP) and the depth of a neuromuscular blockade (NMB) induced pharmacologically, by stimulation of the brachial plexus at the humeral level and recording evoked changes in arterial pressure. MATERIAL AND METHOD: Clinical, single-centre, open-controlled study with 32 adult patients ASA I-III for scheduled elective surgery under general anaesthesia in supine position, for the validation of neuromuscular monitoring, comparing the values obtained from neuromuscular relaxation TOF-Cuff with those obtained by mechanomyography (MMG) (control method) during the recovery phase of NMB, when a TOF ratio>0.7 and>0.9 (primary endpoint) were reached respectively. And an additional consecutive study of 17 patients for validation of NIBP monitoring with TOF-Cuff device vs invasive blood pressure measured by an intra-arterial catheter. All data were analyzed using the Bland-Altman method. RESULTS: Recovery from NMB measured with the TOF-Cuff was earlier compared to MMG. Comparing TOF-ratio>0.9 measured with TOF-Cuff vs TOF-ratio>0.7 with MMG, a specificity of 91% and a positive predictive value of 84% were obtained. In NIBP measurement, the mean error and standard deviation of both systolic blood pressure (1.6±7mmHg) and diastolic blood pressure (-3.4±6.3) were within the European accuracy requirements for medical devices. CONCLUSIONS: The TOF-Cuff device has been shown to be valid and safe in the monitoring of NMB and in the measurement of NIBP, with no patient presenting any adverse events, skin-level lesions or residual pain. It is not interchangeable with MMG, having a TOF-ratio>0.9 quantified by the TOF-Cuff device, a good correlation with a TOF-ratio>0.7 on MMG.