Monitorización intraoperatoria del bloqueo neuromuscular y la presión arterial con un solo dispositivo (TOF-Cuff): estudio comparativo con la mecanomiografía y la presión arterial invasiva / Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): A comparative study with mechanomyography and invasive blood pressure

Objetivo. Determinar la capacidad del dispositivo TOF-Cuff (manguito de presión modificado que incluye electrodos de estimulación) para monitorizar la presión arterial no invasiva (PANI) y el nivel de bloqueo neuromuscular (BNM) inducido farmacológicamente. Material y método. Estudio observacional, prospectivo, de 32 pacientes adultos ASA I-III programados para cirugía bajo anestesia general, para la validación de la monitorización del BNM con el dispositivo TOF-Cuff vs. mecanomiografía (MMG, método control) durante la fase de recuperación del BNM, cuando se alcanzó un TOF-ratio de 0,9 con TOF-Cuff y de 0,7 con la MMG (variable principal). Para completar el estudio principal se realizó un estudio adicional consecutivo al anterior y que incluyó a 17 pacientes para validar el dispositivo TOF-Cuff en la monitorización de la PANI en comparación con la presión arterial invasiva a nivel de la arteria radial (método control). Los datos fueron analizados mediante el método de Bland-Altman. Resultados. Se produjo un adelanto de la recuperación medida con TOF-Cuff respecto a la mecanomiografía. Al comparar un TOF-ratio>0,9 cuantificado mediante TOF-Cuff con un TOF-ratio>0,7 en la MMG tuvo una especificidad del 91% y un valor predictivo positivo del 84%. En la medición de la PANI, el error medio y la desviación estándar tanto de la presión arterial sistólica (1,6±7mmHg) como diastólica (−3,4±6,3) estuvieron dentro de los requisitos europeos de precisión para aparatos sanitarios. Conclusiones. El dispositivo TOF-Cuff ha mostrado ser válido y seguro en la monitorización del BNM y en la medición de la PANI, no presentando ningún paciente acontecimientos adversos, lesiones a nivel de la piel o dolor residual. No es intercambiable con la MMG, teniendo un TOF-ratio>0,9 cuantificado mediante el dispositivo TOF-Cuff, una buena correlación con un TOF-ratio>0,7 en la MMG (AU)

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 (AU)

Respuesta a la carta al director: «Existe realmente consenso entre los anestesistas y los cirujanos sobre el bloqueo neuromuscular: algunas consideraciones metodológicas sobre el estudio AQUILES» / Respose to the letter to the editor: "Is there a real consensus among anaesthetists and surgeons about the neuromuscular block? Methodological considerations about the ACHILLES study"

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Monitoring intraoperative neuromuscular blockade and blood pressure with one device (TOF-Cuff): A comparative study with mechanomyography and invasive blood pressure. / Monitorización intraoperatoria del bloqueo neuromuscular y la presión arterial con un solo dispositivo (TOF-Cuff): estudio comparativo con la mecanomiografía y la presión arterial invasiva.

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.

Recomendaciones sobre el uso de bloqueo neuromuscular profundo por parte de anestesiólogos y cirujanos. Consenso AQUILES (Anestesia QUIrúrgica para Lograr Eficiencia y Seguridad) / Recommendations on the use of deep neuromuscular blockade by anaesthesiologists and surgeons. AQUILES (Anestesia QUIrúrgica para Lograr Eficiencia y Seguridad) Consensus

Introducción. El bloqueo neuromuscular facilita la manipulación de la vía aérea, la ventilación y procedimientos quirúrgicos, pero no hay un consenso a nivel nacional que facilite la práctica clínica habitual. El objetivo fue conocer el grado de acuerdo entre anestesiólogos y cirujanos sobre el uso clínico del bloqueo neuromuscular, para establecer recomendaciones de mejora de su empleo durante un procedimiento anestésico-quirúrgico. Métodos. Estudio de consenso multidisciplinar en España, que incluyó anestesiólogos expertos en bloqueo neuromuscular (n=65) y cirujanos generales (n=36). Se utilizó metodología Delphi. Cuestionario con 17 preguntas consensuado por un comité científico, al que respondieron los expertos en dos olas. El cuestionario incluyó preguntas sobre: tipo de cirugía, tipo de paciente, beneficios/perjuicios durante y después de la cirugía, repercusión de la monitorización objetiva y del uso de fármacos reversores, la viabilidad de abordaje multidisciplinar y eficiente del procedimiento quirúrgico, enfocado en el grado de bloqueo neuromuscular. Resultados. Se establecieron cinco recomendaciones: 1) el bloqueo neuromuscular profundo es muy adecuado en cirugía abdominal (grado de acuerdo 94,1%), y 2) en pacientes con obesidad (76,2%); 3) el mantenimiento del bloqueo neuromuscular profundo hasta el final de la cirugía puede ser beneficioso en aspectos clínicos, como inmovilidad del paciente o mejor acceso quirúrgico (86,1 y 72,3%); 4) la monitorización cuantitativa y la disponibilidad de reversores del bloqueo neuromuscular es recomendable (89,1%); 5) se recomiendan protocolos de actuación conjuntos entre anestesiólogos y cirujanos. Conclusiones. La colaboración entre anestesiólogos y cirujanos generales, ha permitido establecer una serie de recomendaciones genéricas sobre el uso de bloqueo neuromuscular profundo en cirugía abdominal (AU)

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 (AU)

Recommendations on the use of deep neuromuscular blockade by anaesthesiologists and surgeons. AQUILES (Anestesia QUIrúrgica para Lograr Eficiencia y Seguridad) Consensus. / Recomendaciones sobre el uso de bloqueo neuromuscular profundo por parte de anestesiólogos y cirujanos. Consenso AQUILES (Anestesia QUIrúrgica para Lograr Eficiencia y Seguridad).

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.

[Efficacy of sugammadex in the reversal of neuromuscular blockade induced by rocuronium in long-duration surgery: under inhaled vs. intravenous anesthesia]. / Eficacia de la reversión con sugammadex del bloqueo neuromuscular inducido por rocuronio en cirugía de larga duración. Comparación del efecto de la anestesia inhalatoria frente a intravenosa.

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.

Eficacia de la reversión con sugammadex del bloqueoneuromuscular inducido por rocuronio en cirugía de larga duración. Comparación del efecto de la anestesia inhalatoria frente a intravenosa / Efficacy of sugammadex in the reversal of neuromuscular blockade induced by rocuronium in long-duration surgery: under inhaled vs. intravenous anesthesia

OBJETIVOS: Sugammadex revierte el bloqueo neuromuscularinducido por bloqueantes neuromuscularesaminoesteroideos mediante su encapsulación. En esteestudio comparamos la eficacia y seguridad de la reversióncon sugammadex del bloqueo mantenido con rocuronioen cirugía de larga duración con anestesia inhalatoriao intravenosa.PACIENTES Y MÉTODOS: Estudio multicéntrico, prospectivo,randomizado, doble ciego, en 20 pacientes (18-69 años), ASA I-III, programados para cirugía electivade igual o más de 120 minutos de duración. Se indujo laanestesia con propofol, remifentanilo y rocuronio 0,6mg.kg-1, monitorizándose la función neuromuscularmediante aceleromiografía. El mantenimiento se realizó,previa aleatorización, con sevoflurano o anestesia intravenosatotal con propofol, utilizándose en ambos gruposperfusión de remifentanilo para analgesia y rocuroniopara mantener un bloqueo ≥ 90%. Al finalizar la intervenciónse administró sugammadex 2 mg.kg-1 a la reapariciónde T2, midiendo el tiempo hasta la recuperaciónde un ratio T4/T1 de 0,7, 0,8, y 0,9 (variable principal).Se monitorizó la PAM y FC basal, y a los 2, 5, 10 y 30minutos (variables secundarias) de la reversión.RESULTADOS: El consumo de rocuronio y el tiempodesde el inicio de la administración de sugammadex hastaun ratio del TOF de 0,9 fue menor para el sevofluoranoque para propofol [media (DE)], 1,46 (0,30) min frentea 1,89 (0,62) min, sin diferencias significativas. Nohubo signos de recurarización ni efectos adversos relacionados.CONCLUSIONES: Sugammadex revierte de forma eficazy segura, en menos de dos minutos, el bloqueo mantenidocon rocuronio durante intervenciones de larga duración,tanto en anestesia inhalatoria como intravenosa.La interacción de los bloqueantes neuromusculares consevofluorano parece no influir en el tiempo de reversiónde sugammadex en este tipo de intervenciones (AU)

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BACKGROUND AND OBJECTIVE: Sugammadex reversesneuromuscular blockade induced by aminosteroidagents by encapsulating these agents. The objective ofthis study was to compare the efficacy and safety ofsugammadex to reverse a rocuronium-inducedneuromuscular blockade in long-duration surgery inassociation with inhaled or intravenous anesthesia.PATIENTS AND METHODS: We performed a randomized,double-blind, multicenter trial of 20 ASA 1-3 patientsaged between 18 and 69 years and scheduled for electivesurgery lasting at least 120 minutes. Anesthesia wasinduced with remifentanil and rocuronium at a dosage of0.6 mg·kg-1, and neuromuscular function was monitoredby means of acceleromyography. After randomization,anesthesia was maintained with sevoflurane or withpropofol for total intravenous anesthesia. Patients in bothgroups also received an infusion of remifentanil foranalgesia and rocuronium to maintain a block of greaterthan 90%. After surgery, sugammadex was administeredat a dosage of 2 mg·kg-1 on reappearance of the secondtrain-of-four (TOF) twitch (T2) and the times untilrecovery of T4/T1 ratios of 0.7, 0.8, and 0.9 (mainendpoints). Mean arterial pressure and heart rate wererecorded at baseline and after 2, 5, 10, and 30 minutes(secondary outcome measures).RESULTS: Although less rocuronium was consumed inthe sevoflurane group than in the propofol group and (..)(AU)

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