RESUMO
Abstract Background: Sugammadex has made it possible to reverse any type of rocuronium-induced block quickly and safely. The most frequent neuromuscular blockade is the moderate one where doses smaller than those recommended by the industry could get a full reversal. Objective: We aimed to evaluate the effectiveness of half the industry recommended dose of sugammadex to reverse a moderate neuromuscular block. Methods: Unicenter phase IV clinical trial that included 34 patients undergoing laparoscopic cholecystectomy. Intravenous general anesthesia was induced, with acceleromyographic monitoring of the neuromuscular block. After the intervention, the block was reversed with all or half the dose of sugammadex recommended for moderate blocks, using a blinded syringe. Results: Patient characteristics of the 2 groups were similar. Mean time to recovery was 3.6± 1.7minutes for the study group and 3.1 ± 1.7minutes for the control group (P=0.42). Reversal of the block was complete with a single dose of sugammadex in all patients. There was an important linear correlation between depth of block and time to recovery. Conclusion: Intraoperative monitoring is essential to allow us to individualize the dose of the neuromuscular blocking agent. To reverse a moderate block under neuromuscular monitoring, a dose of 1 mg/kg is sufficient in most cases and is equally safe and effective.
Resumen Introducción: El sugammadex permite revertir cualquier tipo de bloqueo inducido por rocuronio de forma rápida y segura. El bloqueo neuromuscular más frecuente es el moderado, en el cual dosis inferiores a las recomendadas por la industria podrían revertirlo completamente. Objetivo: Evaluar la efectividad de la mitad de la dosis de sugammadex recomendada por la industria para revertir un bloqueo neuromuscular moderado. Métodos: Ensayo clínico de fase IV en un unico centro que incluyó a 34 pacientes intervenidos de colecistectomía laparoscópica. Se realizó anestesia general intravenosa con monitoreo aceleromiográfico del bloqueo neuromuscular. Tras la intervención, el bloqueo se revirtió con la totalidad o con la mitad de la dosis de sugammadex recomendada para bloqueos moderados, utilizando una jeringa ciega. Resultados: Las características de los pacientes de los dos grupos fueron similares. La media de tiempo de recuperación fue de 3,6 ± 1,7 minutos para el grupo de estudio y de 3,1 ± 1,7 minutos para el grupo de control (p = 0,42). La reversión del bloqueo se completó con una dosis única de sugammadex en todos los pacientes. Hubo una correlación lineal importante entre la profundidad del bloqueo y el tiempo de recuperación. Conclusión: El monitoreo transquirúrgico es esencial para individualizar la dosis del agente de bloqueo neuromuscular. Para revertir un bloqueo moderado bajo monitoreo neuromuscular, una dosis de 1mg/kg es suficiente e igualmente segura y efectiva.
Assuntos
Humanos , Sugammadex , Rocurônio , Anestesia Geral , Bloqueadores Neuromusculares , Monitorização Intraoperatória , Colecistectomia Laparoscópica , Bloqueio Neuromuscular , Dosagem , Monitoração NeuromuscularRESUMO
BACKGROUND: Neoadjuvant therapy (NAT) for pancreatic adenocarcinoma (PDAC) patients has shown promising results in non-randomized trials. This is a multi-institutional phase II trial of NAT in resectable PDAC patients. METHODS: Patients with confirmed resectable PDAC after agreement by two expert radiologists were eligible. Patients received three cycles of GEM (1000 mg/m2/week) plus daily erlotinib (ERL) (100 mg/day). After re-staging, patients without progressive disease underwent 5 weeks of therapy with GEM (300 mg/m2/week), ERL 100 mg/day and concomitant radiotherapy (45 Gy). Efficacy was assessed using tumor regression grade (TRG) and resection margin status. Using a single-arm Simon's design, considering the therapy not useful if R0 < 40% and useful if the R0 > 70% (alpha 5%, beta 10%), 24 patients needed to be recruited. This trial was registered at ClinicalTrials.gov, number NCT01389440. RESULTS: Twenty-five patients were enrolled. Adverse effects of NAT were mainly mild gastrointestinal disorders. Resectability rate was 76%, with a R0 rate of 63.1% among the resected patients. Median overall survival (OS) and disease-free survival (DFS) were 23.8 (95% CI 11.4-36.2) and 12.8 months (95% CI 8.6-17.1), respectively. R0 resection patients had better median OS, compared with patients with R1 resection or not resected (65.5 months vs. 15.5 months, p = 0.01). N0 rate among the resected patients was 63.1%, and showed a longer median OS (65.5 vs. 15.2 months, p = 0.009). CONCLUSION: The results of this study confirm promising oncologic results with NAT for patients with resectable PDAC. Therefore, the present trial supports the development of phase II randomized trials comparing NAT vs. upfront surgery in resectable pancreatic cancer.
