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2.
Br J Anaesth ; 131(2): 202-204, 2023 08.
Artigo em Inglês | MEDLINE | ID: mdl-37246063

RESUMO

Patients requiring neuromuscular block for anaesthesia have a higher risk of adverse postoperative outcomes. The choice of reversal drug and its corresponding dose is critical for improving clinical outcomes. Although drug costs are higher for sugammadex relative to neostigmine, additional factors need to be considered when choosing one drug over the other. New data from a recent study in the British Journal of Anaesthesia indicate cost advantages for sugammadex in low-risk and ambulatory patients, but for neostigmine in high-risk patients. These findings highlight the need to take local and temporal factors into consideration in addition to clinical effectiveness when performing cost analyses for administrative decision-making.


Assuntos
Anestesia , Bloqueio Neuromuscular , Humanos , Sugammadex , Neostigmina , Custos e Análise de Custo , Inibidores da Colinesterase/efeitos adversos
4.
Br J Anaesth ; 130(2): 133-141, 2023 02.
Artigo em Inglês | MEDLINE | ID: mdl-36564246

RESUMO

BACKGROUND: Sugammadex reversal of neuromuscular block facilitates recovery of neuromuscular function after surgery, but the drug is expensive. We evaluated the effects of sugammadex on hospital costs of care. METHODS: We analysed 79 474 adult surgical patients who received neuromuscular blocking agents and reversal from two academic healthcare networks between 2016 and 2021 to calculate differences in direct costs. We matched our data with data from the Healthcare Cost and Utilization Project-National Inpatient Sample (HCUP-NIS) to calculate differences in total costs in US dollars. Perioperative risk profiles were defined based on ASA physical status and admission status (ambulatory surgery vs hospitalisation). RESULTS: Based on our registry data analysis, administration of sugammadex vs neostigmine was associated with lower direct costs (-1.3% lower costs; 95% confidence interval [CI], -0.5 to -2.2%; P=0.002). In the HCUP-NIS matched cohort, sugammadex use was associated with US$232 lower total costs (95% CI, -US$376 to -US$88; P=0.002). Subgroup analysis revealed that sugammadex was associated with US$1042 lower total costs (95% CI, -US$1198 to -US$884; P<0.001) in patients with lower risk. In contrast, sugammadex was associated with US$620 higher total costs (95% CI, US$377 to US$865; P<0.001) in patients with a higher risk (American Society of Anesthesiologists physical status ≥3 and preoperative hospitalisation). CONCLUSIONS: The effects of using sugammadex on costs of care depend on patient risk, defined based on comorbidities and admission status. We observed lower costs of care in patients with lower risk and higher costs of care in hospitalised surgical patients with severe comorbidities.


Assuntos
Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , Adulto , Humanos , Neostigmina/efeitos adversos , Sugammadex/efeitos adversos , Bloqueio Neuromuscular/efeitos adversos , Custos Hospitalares , Rocurônio
5.
J Clin Anesth ; 77: 110627, 2022 05.
Artigo em Inglês | MEDLINE | ID: mdl-34990997

RESUMO

STUDY OBJECTIVE: Due to excessive sugammadex expenditures at our institution, we designed dosing guidelines that utilize adjusted body weight and informatics-based tools aimed at reducing variability in dosing practices. DESIGN: We retrospectively reviewed rates of high-dose sugammadex administration in three phases: Pre-intervention - May 2018 to November 2018; First intervention - November 2018 to April 2019; and Second intervention - April 2019 to July 2019. SETTING: Academic medical center in the United States - Vanderbilt University Medical Center (VUMC) PATIENTS: N/A INTERVENTIONS: First, anesthesia providers were educated on adjusted body weight-based dosing guidelines. Providers also received intraoperative decision support displaying a patient's actual and adjusted body weight along with rates of high-dose (>200 mg) sugammadex administration for each respective provider. Second, we implemented an email-feedback system to remind providers of the new guidelines. MEASUREMENTS: Weekly rate of high-dose sugammadex cases. MAIN RESULTS: During the pre-intervention stage, 1556 (12.3%) cases involved high-dose sugammadex. Comparatively, 550 (4.3%) and 187 (3.1%) high-dose sugammadex cases occurred during the first and second intervention stages, respectively. Segmented regression analysis demonstrated a significant rate change of -3.51% (95% CI: -5.64%, -1.38%) in sugammadex dosing practices after provider education and the implementation of digital improvement initiatives but failed to reveal a significant change after implementation of the email-feedback system. Overall, our interventions were associated with $2563.05 in estimated weekly savings of sugammadex expenditures. CONCLUSIONS: Provider education and digital quality improvement was associated with reduced rates of high-dose sugammadex administration, generating cost savings at a large academic medical institution.


Assuntos
Bloqueio Neuromuscular , Preparações Farmacêuticas , Correio Eletrônico , Retroalimentação , Gastos em Saúde , Humanos , Neostigmina , Estudos Retrospectivos , Sugammadex
6.
Anesth Analg ; 133(6): 1437-1450, 2021 12 01.
Artigo em Inglês | MEDLINE | ID: mdl-34784330

RESUMO

BACKGROUND: Neuromuscular blockade (NMB) is a critical part of many surgical procedures. Data on practice patterns of NMB agents (NMBAs) and NMB reversal in recent years in the US ambulatory surgical care setting are limited. METHODS: This retrospective analysis of US adult outpatients was conducted using the Premier Healthcare Database. We describe anesthesia practice trends in NMB management and assess the association of patient, procedural, and site characteristics with NMB reversal approach using multivariable logistic regression. RESULTS: Approximately 5.2 million outpatient surgical encounters involving NMB and 4.6 million involving rocuronium or vecuronium between January 2014 and June 2019 were included. Following the introduction of sugammadex to US clinical practice (~2016), there was an increased use of rocuronium or vecuronium and a decrease in succinylcholine alone. Before 2016, NMB was pharmacologically reversed with neostigmine in approximately two-thirds of outpatient encounters. Over time, active reversal increased; by 2019, 42.3% and 36.0% of encounters were reversed by neostigmine and sugammadex, respectively, with 21.7% undergoing spontaneous recovery. Choice of NMBA (rocuronium or vecuronium alone), time since 2016, obesity, peripheral vascular disease, and procedures on the digestive, ocular, and female genital systems (vs musculoskeletal procedures) were independently and positively associated with pharmacologic reversal (versus spontaneous reversal). Conversely, advanced age; Western geography; and cardiovascular, endocrine, hemic/lymphatic, respiratory, and ear, nose, and throat procedures were independently and negatively associated with pharmacologic reversal of NMB.Among pharmacologic reversals, time since 2016 was positively and independently associated with sugammadex compared with neostigmine (odds ratios [ORs], ranged from 1.8 in 2017 to 3.2, P < .0001 in 2019). Those administered rocuronium or vecuronium without succinylcholine, with increased age and history of certain comorbidities, and those undergoing ocular or respiratory procedures (compared with musculoskeletal) were positively associated with reversal with sugammadex and endocrine procedure negatively and independently associated with reversal with sugammadex. There was variability in the association of several factors with NMB reversal choices by geographic region, particularly in patients' race, ethnicity, and size of affiliated hospital. CONCLUSIONS: Overall, active pharmacological reversal of NMB increased in US adult outpatients following the introduction of sugammadex, although there remains significant practice variability. The multifactorial relationship between patient-, procedural-, and environmental-level characteristics and NMB management is rapidly evolving. Additional research on how these anesthesia practice patterns may be impacted by the shift to the ambulatory care setting and how they may impact patient outcomes and health disparities is warranted.


Assuntos
Procedimentos Cirúrgicos Ambulatórios/métodos , Procedimentos Cirúrgicos Ambulatórios/estatística & dados numéricos , Bloqueio Neuromuscular/métodos , Bloqueio Neuromuscular/estatística & dados numéricos , Adolescente , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Período de Recuperação da Anestesia , Comorbidade , Bases de Dados Factuais , Etnicidade , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Neostigmina , Fármacos Neuromusculares Despolarizantes , Fármacos Neuromusculares não Despolarizantes , Estudos Retrospectivos , Rocurônio , Succinilcolina , Sugammadex , Estados Unidos , Brometo de Vecurônio , Adulto Jovem
8.
Adv Ther ; 38(5): 2689-2708, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33871823

RESUMO

INTRODUCTION: Sugammadex rapidly reverses the effects of rocuronium- and vecuronium-induced neuromuscular blockade (NMB), offering a more complete and predictable NMB recovery than cholinesterase inhibitors. Despite clinical benefits, cost pressures on hospital budgets influence the choice of the NMB reversal method. This study evaluated clinical and healthcare system payer's budget impacts associated with sugammadex in the US for routine reversal of moderate or deep rocuronium- or vecuronium-induced NMB in adults undergoing surgery. METHODS: A 1-year decision analytic model was constructed reflecting a set of procedures using rocuronium or vecuronium that resulted in moderate or deep NMB at the end of surgery. Two scenarios were considered for a hypothetical cohort of 100,000 patients: without sugammadex versus with sugammadex. Comparators included neostigmine (+glycopyrrolate) and no neuromuscular blocking agents (NMBAs). Total costs (in 2019 US dollars) to a healthcare system [net of costs of reversal agents and overall cost offsets via reduction in postoperative pulmonary complications (PPC)] were compared. RESULTS: A total of 9971 surgical procedures utilized rocuronium or vecuronium, resulting in moderate (91.0% of cases) or deep (9.0%) blockade at the end of surgeries. In the with sugammadex scenario, sugammadex replaced neostigmine in 4156 of 9585 procedures versus the without sugammadex scenario that used only neostigmine for NMB reversal. Introducing sugammadex reduced PPC events by 12% (58 cases) among the modeled procedures, leading to a budget impact of -$3,079,703 (-$309 per modeled procedure, or a 10.9% reduction in total costs). The results did not vary qualitatively in one-way sensitivity analyses. CONCLUSIONS: The additional costs of sugammadex for the reversal of rocuronium- or vecuronium-induced NMB could be offset by improved outcomes (i.e., reduced PPC events), and potentially lead to overall healthcare budgetary savings versus reversal with neostigmine or spontaneous recovery. This study provides insights into savings that can be obtained beyond the anesthesia budget, reducing the broader clinical and budgetary burden on the hospital.


Assuntos
Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Adulto , Humanos , Neostigmina , Sugammadex
9.
BMC Anesthesiol ; 21(1): 55, 2021 02 16.
Artigo em Inglês | MEDLINE | ID: mdl-33593283

RESUMO

BACKGROUND: Neuromuscular blocking (NMB) agents are often administered to facilitate tracheal intubation and prevent patient movement during surgical procedures requiring the use of general anesthetics. Incomplete reversal of NMB, can lead to residual NMB, which can increase the risk of post-operative pulmonary complications. Sugammadex is indicated to reverse neuromuscular blockade induced by rocuronium or vecuronium in adults. The aim of this study is to estimate the clinical and economic impact of introducing sugammadex to routine reversal of neuromuscular blockade (NMB) with rocuronium in Spain. METHODS: A decision analytic model was constructed reflecting a set of procedures using rocuronium that resulted in moderate or deep NMB at the end of the procedure. Two scenarios were considered for 537,931 procedures using NMB agents in Spain in 2015: a scenario without sugammadex versus a scenario with sugammadex. Comparators included neostigmine (plus glycopyrrolate) and no reversal agent. The total costs for the healthcare system were estimated from the net of costs of reversal agents and overall cost offsets via reduction in postoperative pneumonias and atelectasis for which incidence rates were based on a Spanish real-world evidence (RWE) study. The model time horizon was assumed to be one year. Costs were expressed in 2019 euros (€) and estimated from the perspective of a healthcare system. One-way sensitivity analysis was carried out by varying each parameter included in the model within a range of +/- 50%. RESULTS: The estimated budget impact of the introduction of sugammadex to the routine reversal of neuromuscular blockade in Spanish hospitals was a net saving of €57.1 million annually. An increase in drug acquisition costs was offset by savings in post-operative pulmonary events, including 4806 post-operative pneumonias and 13,996 cases of atelectasis. The total cost of complications avoided was €70.4 million. All parameters included in the model were tested in sensitivity analysis and were favorable to the scenario with sugammadex. CONCLUSIONS: This economic analysis shows that sugammadex can potentially lead to cost savings for the reversal of rocuronium-induced moderate or profound NMB compared to no reversal and reversal with neostigmine in the Spanish health care setting. The economic model was based on data obtained from Spain and from assumptions from clinical practice and may not be valid for other countries.


Assuntos
Bloqueio Neuromuscular/métodos , Fármacos Neuromusculares não Despolarizantes/antagonistas & inibidores , Segurança do Paciente/economia , Segurança do Paciente/estatística & dados numéricos , Sugammadex/economia , Sugammadex/farmacologia , Humanos , Bloqueio Neuromuscular/economia , Fármacos Neuromusculares não Despolarizantes/economia , Espanha
10.
J Clin Anesth ; 67: 110027, 2020 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-32980763

RESUMO

STUDY OBJECTIVE: This report analyzes the comparative costs, efficacy and side effects of a newer, more expensive reversal drug, sugammadex, with its generic counterpart, neostigmine combined with glycopyrrolate, or no reversal agent when used routinely to reverse rocuronium-induced neuromuscular blockade in adult patients. DESIGN: Cost analysis. METHODS: We constructed a decision model to analyze the costs associated with the choice of reversal drug and differences in reversal time, occurrence of postoperative nausea or vomiting (PONV), and residual blockade requiring unplanned postoperative mechanical ventilation (UPMV). We selected variables that demonstrated meaningful differences in meta-analyses of published studies and/or had significant associated costs. We used data from local hospital system information, meta-analysis of published studies, and the general literature to construct base-case scenarios and sensitivity analyses. We performed the analysis from the perspective of a single hospital system. Costs were in 2019 U.S. dollars. RESULTS: Cost analysis suggested that reversal with sugammadex is preferable to neostigmine or no reversal drug when operating room (OR) time was valued at ≥$8.60/min (base case $32.49/min). Net costs of sugammadex were less than no treatment or neostigmine reversal when the probability of UPMV exceeded 0.019 and 0.036, respectively. Neither sugammadex nor neostigmine reversal was preferable to no treatment in a base-case analysis that considered the effect of the reversal agent on only drug and PONV costs, disregarding costs of OR time or UPMV. CONCLUSIONS: Routine reversal with sugammadex is preferable to choosing neostigmine or no reversal drug when accounting for potential savings in OR time. Sugammadex might also be a reasonable choice for patients at high risk of UPMV. If the cost of OR time is not considered, the analysis does not support the routine use of sugammadex in patients with perceived increased risk or solely to reduce PONV.


Assuntos
Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Adulto , Inibidores da Colinesterase/efeitos adversos , Custos e Análise de Custo , Humanos , Neostigmina/efeitos adversos , Bloqueio Neuromuscular/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Rocurônio , Sugammadex/efeitos adversos , gama-Ciclodextrinas/efeitos adversos
11.
Sci Rep ; 10(1): 11179, 2020 07 07.
Artigo em Inglês | MEDLINE | ID: mdl-32636444

RESUMO

This study evaluated the effects of sugammadex at conventional doses of 2 and 4 mg/kg on the coagulation profile by analyzing thromboelastographic parameters and performing a traditional laboratory coagulation analysis. A total of 100 patients undergoing arthroscopic shoulder surgery were enrolled. The patients were randomly divided into the 2 mg and 4 mg groups. The laboratory coagulation test and thromboelastographic analysis were performed before and 15 min after administering sugammadex. Prothrombin time (PT) was significantly prolonged after sugammadex administration than before it in intragroup comparisons of the 2 mg group (12.8 ± 0.6 s vs. 13.6 ± 0.7 s, p < 0.001) and the 4 mg group (13.0 ± 0.5 s vs. 13.7 ± 0.5 s, p < 0.001). R time, derived from thromboelastography, was also significantly prolonged after sugammadex administration (4.7 ± 1.8 min vs. 5.8 ± 2.1 min, p = 0.005). In conclusion, the conventional doses of 2 or 4 mg/kg sugammadex prolonged PT. Sugammadex 4 mg/kg also prolonged R time, although the value was within the normal range. Therefore, physicians should be cautious with the higher sugammadex dose, particularly in patients with a high risk of bleeding because the higher dose was associated with less coagulation.Trial registration: KCT0002133 (https://cris.nih.go.kr).


Assuntos
Coagulação Sanguínea/efeitos dos fármacos , Fármacos Neuromusculares/efeitos adversos , Sugammadex/efeitos adversos , Artroscopia/efeitos adversos , Artroscopia/métodos , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/farmacologia , Fármacos Neuromusculares/uso terapêutico , Hemorragia Pós-Operatória/etiologia , Protrombina/análise , Sugammadex/farmacologia , Sugammadex/uso terapêutico , Tromboelastografia
12.
Br J Hosp Med (Lond) ; 81(6): 1-2, 2020 Jun 02.
Artigo em Inglês | MEDLINE | ID: mdl-32589529
13.
A A Pract ; 14(7): e01223, 2020 May.
Artigo em Inglês | MEDLINE | ID: mdl-32539276

RESUMO

The relatively high cost of sugammadex compared to neostigmine limits its widespread use to reverse neuromuscular blockade, despite its faster onset and more complete clinical effect. While ensuring timely access to sugammadex is important in improving perioperative safety, it is also vital to control unnecessary spending. We describe a quality improvement initiative to reduce excess spending on sugammadex while improving access for anesthesia providers. Monthly spending on sugammadex decreased by 52% ($70,777 vs $33,821), while medication access increased via automated medication dispensers in each operating room. Clinical usage decreased by one-third, with presumed increased adherence to dosing guidelines.


Assuntos
Melhoria de Qualidade , Sugammadex/economia , Anestesia/economia , Serviço Hospitalar de Anestesia/economia , Redução de Custos , Humanos , Bloqueio Neuromuscular/economia , Serviço de Farmácia Hospitalar/economia , Sugammadex/uso terapêutico , Resíduos
15.
Anesthesiology ; 131(5): 1036-1045, 2019 11.
Artigo em Inglês | MEDLINE | ID: mdl-31634247

RESUMO

BACKGROUND: The authors observed increased pharmaceutical costs after the introduction of sugammadex in our institution. After a request to decrease sugammadex use, the authors implemented a cognitive aid to help choose between reversal agents. The purpose of this study was to determine if sugammadex use changed after cognitive aid implementation. The authors' hypothesis was that sugammadex use and associated costs would decrease. METHODS: A cognitive aid suggesting reversal agent doses based on train-of-four count was developed. It was included with each dispensed reversal agent set and in medication dispensing cabinet bins containing reversal agents. An interrupted time series analysis was performed using pharmaceutical invoices and anesthesia records. The primary outcome was the number of sugammadex administrations. Secondary outcomes included total pharmaceutical acquisition costs of neuromuscular blocking drugs and reversal agents, adverse respiratory events, emergence duration, and number of neuromuscular blocking drug administrations. RESULTS: Before cognitive aid implementation, the number of sugammadex administrations was increasing at a monthly rate of 20 per 1,000 general anesthetics (P < 0.001). Afterward, the monthly rate was 4 per 1,000 general anesthetics (P = 0.361). One month after cognitive aid implementation, the number of sugammadex administrations decreased by 281 per 1,000 general anesthetics (95% CI, 228 to 333, P < 0.001). In the final study month, there were 509 fewer sugammadex administrations than predicted per 1,000 general anesthetics (95% CI, 366 to 653; P < 0.0001), and total pharmaceutical acquisition costs per 1,000 general anesthetics were $11,947 less than predicted (95% CI, $4,043 to $19,851; P = 0.003). There was no significant change in adverse respiratory events, emergence duration, or administrations of rocuronium, vecuronium, or atracurium. In the final month, there were 75 more suxamethonium administrations than predicted per 1,000 general anesthetics (95% CI, 32 to 119; P = 0.0008). CONCLUSIONS: Cognitive aid implementation to choose between reversal agents was associated with a decrease in sugammadex use and acquisition costs.


Assuntos
Cognição , Custos de Medicamentos/tendências , Análise de Séries Temporais Interrompida/tendências , Bloqueio Neuromuscular/tendências , Sistemas de Informação em Salas Cirúrgicas/tendências , Sugammadex/uso terapêutico , Anestésicos Gerais/economia , Anestésicos Gerais/uso terapêutico , Feminino , Pessoal de Saúde/economia , Pessoal de Saúde/tendências , Humanos , Análise de Séries Temporais Interrompida/economia , Masculino , Bloqueio Neuromuscular/economia , Sistemas de Informação em Salas Cirúrgicas/economia , Sugammadex/economia
16.
Br J Anaesth ; 122(3): 370-378, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30770055

RESUMO

BACKGROUND: Sugammadex is associated with fewer postoperative complications, but its impact on 30-day unplanned readmission is unclear. METHODS: This was a single-centre retrospective observational study of patients after major abdominal surgery between 2010 and 2017, where rocuronium was the only neuromuscular blocker used. The primary endpoint was the difference in incidence of 30-day unplanned readmission between reversal with sugammadex or neostigmine. The secondary endpoints were the length of hospital stay after surgery and related hospital charges (total charges excluding those related to surgery and anaesthesia). Analysis included propensity score matching and generalised mixed-effects modelling. RESULTS: Mixed-effects logistic regression analysis of 1479 patients (sugammadex: 355; neostigmine: 1124) showed that the incidence of 30-day unplanned readmission was 34% lower (odds ratio [OR]: 0.66, 95% confidence interval [CI]: 0.46-0.96, P=0.031), the length of hospital stay was 20% shorter (exponential regression coefficient: 0.80, 95% CI: 0.77-0.83, P<0.001), and related hospital charges were 24% lower (exponential regression coefficient: 0.76, 95% CI: 0.67-0.87, P<0.001) in the sugammadex group than in the neostigmine group. For patients living ≥50 km from the hospital, the incidence of 30-day unplanned readmission was 68% lower in the sugammadex group than in the neostigmine group (OR: 0.32, 95% CI: 0.13-0.79, P=0.014), while it was not significant for patients living <50 km from the hospital (P=0.319). CONCLUSIONS: Compared with neostigmine, reversal of rocuronium with sugammadex after major abdominal surgery was associated with a lower incidence of 30-day unplanned readmission, a shorter hospital stay, and lower related hospital charges.


Assuntos
Abdome/cirurgia , Período de Recuperação da Anestesia , Inibidores da Colinesterase/administração & dosagem , Neostigmina/administração & dosagem , Readmissão do Paciente/estatística & dados numéricos , Sugammadex/administração & dosagem , Adulto , Idoso , Idoso de 80 Anos ou mais , Feminino , Preços Hospitalares/estatística & dados numéricos , Humanos , Tempo de Internação/estatística & dados numéricos , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Adulto Jovem
18.
Lima; IETSI; 2019.
Não convencional em Espanhol | BRISA | ID: biblio-1009360

RESUMO

INTRODUCCIÓN: El presente dictamen expone la evaluación de la eficacia y seguridad de sugammadex comparado con neostigmina en pacientes adultos con distrofia miotónica sometidos a cirugía bajo anestesia general. El manejo anestésico en pacientes con enfermedades neuromusculares, podría ser todo un desafío para el médico anestesiólogo ante las posibles complicaciones que se puedan presentar, sea por las características propias de la enfermedad o por los efectos que puedan ocasionar los agentes anestésicos y otros fármacos empleados durante el procedimiento anestésico. La distrofia miotónica es una enfermedad neuromuscular de progresión lenta y predominantemente hereditaria. Se manifiesta mayormente en la tercera o cuarta década de vida. Esta puede presentarse bajo dos formas: a) distrofia miotónica de tipo 1 o enfermedad de Steinert, la cual se caracteriza por miotonía y daño multiorgánico; y, b) distrofia miotónica 2, conocida como una versión más leve de la distrofia miotónica 1 (miopatía miotónica proximal, PROMM), que se produce por una expansión en la repetición del CCTG (Citosina - Citosina - Timina - Guanina) en el gen de la proteína zinc finger 9 en el cromosoma 3. En general, estas enfermedades se caracterizan clínicamente por rigidez muscular y alteración de la relajación - contracción. Para la reversión del bloqueo neuromuscular, dentro del Petitorio Farmacológico de EsSalud se cuenta con neostigmina metilsulfato (piridostigmina está restringida para uso de la especialidad de neurología) como agente ampliamente usado internacionalmente para este fin. Sin embargo, debido a las características de los pacientes con distrofia miotónica, resulta necesario evaluar si los nuevos agentes para la reversión del bloqueo neuromuscular ofrecen mejor beneficio clínico neto en este grupo de pacientes. TECNOLOGÍA SANITARIA DE INTERÉS: Sugammadex (Bridion®) es una gamma ciclodextrina modificada, que actúa como un agente selectivo formando complejos con los bloqueantes neuromusculares rocuronio o vecuronio en plasma, originando una reversión del bloqueo neuromuscular inducido por estos dos fármacos. Ha sido autorizado para su comercialización en los Estados Unidos por la Administración de Drogas y Medicamentos; en Europa por la Agencia Europea de Medicamentos; y por la Dirección General de Medicamentos, Insumos y Drogas del Perú, para la reversión del bloqueo neuromuscular inducido por rocuronio o vecuronio en adultos. OBJETIVO: el objetivo de la presente evaluación de tecnología sanitaria fue evaluar la eficacia y seguridad del uso de sugammadex comparado con neostigmina en pacientes con distrofia miotónica sometidos a cirugía bajo anestesia general. METODOLOGÍA: Se incluye en el presente dictamen, la revisión de la literatura publicada a la fecha (incluyó alertas diarias de PubMed sobre nuevas publicaciones) y la síntesis de resultados con respecto al uso de sugammadex comparado con neostigmina para reversión del bloqueo neuromuscular en pacientes con distrofia miotónica sometidos a cirugía bajo anestesia general. No se identificó ningún ensayo clínico aleatorizado que evalúe la eficacia y seguridad de sugammadex comparado con neostigmina en la población de interés. Por lo tanto, se adicionó una búsqueda de estudios observacionales acerca del uso de sugammadex o neostigmina en pacientes con distrofia miotónica. Se incluyó una guía de práctica clínica del grupo Orphanet y dos estudios observacionales (Mathieu et al. 1997, y Weingarten et al. 2010) que incluyeron a pacientes con distrofia miotónica tratados con neostigmina. No se identificaron estudios observacionales que comparen el uso de sugammadex y neostigmina en la población de la pregunta PICO de interés. RESULTADOS: La guía incluida menciona a sugammadex como un fármaco que puede ser empleado sin complicaciones en la reversión del bloqueo neuromuscular producido por vecuronio o rocuronio. En cuanto al uso de agentes anticolinesterásicos, tales como la neostigmina, la guía menciona que puede causar lesiones musculares graves. No obstante, la guía no cita evidencia que permita evaluar bajo qué características clínicas y dosis se presentarían las complicaciones con agentes anticolinesterásicos o cuál es el beneficio clínico adicional que brinda sugammadex en la población de la pregunta PICO del presente dictamen. CONCLUSIONES: En el presente documento se evaluó la evidencia científica publicada hasta la actualidad en relación al uso de sugammadex comparado con neostigmina en pacientes con distrofia miotónica sometidos a cirugía bajo anestesia general. No se identificaron ensayos clínicos aleatorizados que evalúen la eficacia y seguridad de sugammadex comparado con neostigmina en pacientes con distrofia miotónica sometidos a cirugía bajo anestesia general. Por lo tanto, se adicionó una búsqueda de estudios observacionales acerca del uso de sugammadex o neostigmina en pacientes con distrofia miotónica. Así, se identificó una única guía que menciona a sugammadex como un fármaco que puede ser empleado sin complicaciones en la reversión del bloqueo neuromuscular producido por vecuronio o rocuronio. En cuanto al uso de agentes anticolinesterásicos, la guía menciona que puede causar lesiones musculares graves. Bajo estas consideraciones, la guía no cita evidencia de calidad que permita evaluar bajo qué características clínicas y dosis se presentarían las complicaciones con agentes anticolinesterásicos o el beneficio clínico adicional que brinda sugammadex en la población de la pregunta PICO del presente dictamen. No encontraron estudios observacionales que incluyan pacientes con distrofia miotónica en los cuales se usó sugammadex. Asimismo, los dos estudios observacionales identificados con el mayor número de casos con distrofia miotónica, mostraron que el uso de neostigmina presentó una respuesta normal sin complicaciones en este tipo de pacientes. Siendo así, y a la fecha, la evidencia identificada no permite conocer el beneficio neto adicional del uso de sugammadex comparado con neostigmina, en pacientes con distrofia miotónica, sometidos a cirugía bajo anestesia general. Así, la inversión de recursos en una tecnología sanitaria con elevado costo sin tener certeza de los beneficios adicionales que se logran frente al uso de neostigmina (incluido en el Petitorio Farmacológico de EsSalud), significaría que la institución deje de invertir en tecnologías que han demostrado sus beneficios para la población asegurada y hace que perfil de costo-oportunidad de sugammadex sea desfavorable para el contexto de EsSalud. Por lo expuesto, el Instituto de Evaluación de Tecnologías en Salud e Investigación-IETSI no aprueba el uso de sugammadex comparado con neostigmina en pacientes con distrofia miotónica sometidos a cirugía bajoanestesia general.


Assuntos
Humanos , Sugammadex/uso terapêutico , Distrofia Miotônica/tratamento farmacológico , Neostigmina/uso terapêutico , Avaliação da Tecnologia Biomédica , Análise Custo-Eficiência
19.
BMC Anesthesiol ; 18(1): 159, 2018 11 06.
Artigo em Inglês | MEDLINE | ID: mdl-30400850

RESUMO

BACKGROUND: Sugammadex, a γ-cyclodextrin derivative, belongs to a new class of selective relaxant binding agents. Sugammadex was approved 10-years ago by the European medicines agency and today is used in clinical anesthesia and emergency medicine globally. In this review, indications for neuromuscular block, the challenge of neuromuscular monitoring and the practice of under-dosing of sugammadex as a potential cost-saving strategy are discussed. MAIN BODY: Reversal of neuromuscular block is important to accelerate the spontaneous recovery of neuromuscular function. Sugammadex is able to reverse a rocuronium- or vecuronium-induced neuromuscular block rapidly and efficiently from every depth of neuromuscular block. However, since sugammadex was introduced in clinical anesthesia, several studies have reported administration of a lower-than-recommended dose of sugammadex. The decision to under-dose sugammadex is often motivated by cost reduction concerns, as the price of sugammadex is much higher than that of neostigmine outside the United States. However, under-dosing of sugammadex leads to an increased risk of recurrence of neuromuscular block after an initial successful (but transient) reversal. Similarly, when not using objective neuromuscular monitoring, under-dosing of sugammadex may result in residual neuromuscular block in the postoperative care unit, with its attendant negative pulmonary outcomes. Therefore, an appropriate dose of sugammadex, based on objective determination of the depth of neuromuscular block, should be administered to avoid residual or recurrent neuromuscular block and attendant postoperative complications. Whether the reduction in perioperative recovery time of the patient can be translated into additional procedural cases performed, faster operative turnover times, or improved organizational resource utilization, has yet to be determined in actual clinical practice that includes verification of neuromuscular recovery prior to tracheal extubation. CONCLUSIONS: The current review addresses the indications for neuromuscular block, the challenge of neuromuscular monitoring, the practice of under-dosing of sugammadex as a potential cost-saving strategy in reversal of deep neuromuscular block, the economics of sugammadex administration and the potential healthcare cost-saving strategies.


Assuntos
Monitoração Neuromuscular/métodos , Fármacos Neuromusculares não Despolarizantes/antagonistas & inibidores , Sugammadex/administração & dosagem , Redução de Custos , Relação Dose-Resposta a Droga , Humanos , Neostigmina/administração & dosagem , Neostigmina/economia , Bloqueio Neuromuscular/métodos , Fármacos Neuromusculares não Despolarizantes/administração & dosagem , Rocurônio/administração & dosagem , Rocurônio/antagonistas & inibidores , Sugammadex/economia , Brometo de Vecurônio/administração & dosagem , Brometo de Vecurônio/antagonistas & inibidores
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