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1.
Curr Opin Anaesthesiol ; 37(4): 338-343, 2024 Aug 01.
Artículo en Inglés | MEDLINE | ID: mdl-38841921

RESUMEN

PURPOSE OF REVIEW: This review article explores the evidence regarding sugammadex (MSD Australia) and its potential interaction with hormonal contraceptives. The impact of recent clinical trials and review articles is examined. RECENT FINDINGS: Recent clinical data suggest that the interaction between sugammadex and estrogen and progesterone concentrations may not be clinically significant and may confer some protection against ovulation. There are no clinical trials reporting interactions between sugammadex and the exogenous hormonal compounds found in oral contraceptive pills. The method of contraception is an important consideration, as sugammadex theoretically affects oral and nonoral, and combined versus single agent methods differently. Two large retrospective database studies have reported two cases of pregnancy postoperatively in patients on hormonal contraceptives whose anesthetic included sugammadex. SUMMARY: Strong clinical evidence to support or refute claims of a significant impact of sugammadex on contraceptive efficacy in women on contraception is lacking. The existing evidence does not suggest a basis for concern regarding the impact of sugammadex on contraception in the perioperative setting.


Asunto(s)
Interacciones Farmacológicas , Sugammadex , gamma-Ciclodextrinas , Humanos , Sugammadex/efectos adversos , Sugammadex/administración & dosificación , Femenino , gamma-Ciclodextrinas/efectos adversos , gamma-Ciclodextrinas/administración & dosificación , Anticonceptivos Orales/efectos adversos , Embarazo
2.
Expert Opin Drug Saf ; 23(7): 845-853, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38938223

RESUMEN

INTRODUCTION: Sugammadex, a novel selective antagonist of non-depolarizing neuromuscular blocking agents, has been shown to rapidly and effectively reverse moderate and deep paralysis in adults and pediatric patients over age 2, improving patient recovery and reducing the risk of postoperative complications. AREAS COVERED: Since the use of sugammadex in patients under age 2 is not widely studied, we aim to provide an overview on the drug's application and potential use in infants and neonates. There is a limited but growing body of evidence for the safe, efficacious use of sugammadex in children under age 2. Relevant studies were identified from the most updated data including case reports, clinical trials, systematic reviews, and meta analyses. EXPERT OPINION: The results suggest that at a dose of 2 to 4 mg/kg of sugammadex can be safely used to rapidly and effectively reverse neuromuscular blockade in neonates and infants; it is non-inferior based on incidence of adverse events compared to neostigmine. Additionally, sugammadex doses between 8 and 16 mg/kg may be used as a rescue agent for infants during 'can't intubate, can't ventilate' crisis. Overall, sugammadex offers new value in the perioperative care of patients under age 2, with further studies warranted to better understand its application and full effect in the pediatric population.


Asunto(s)
Relación Dosis-Respuesta a Droga , Bloqueo Neuromuscular , Fármacos Neuromusculares no Despolarizantes , Sugammadex , Humanos , Sugammadex/administración & dosificación , Sugammadex/efectos adversos , Sugammadex/farmacología , Lactante , Bloqueo Neuromuscular/métodos , Bloqueo Neuromuscular/efectos adversos , Recién Nacido , Factores de Edad , Fármacos Neuromusculares no Despolarizantes/administración & dosificación , Fármacos Neuromusculares no Despolarizantes/efectos adversos , Fármacos Neuromusculares no Despolarizantes/antagonistas & inhibidores , Complicaciones Posoperatorias/prevención & control , Neostigmina/administración & dosificación , Neostigmina/efectos adversos , Atención Perioperativa/métodos
3.
BMC Anesthesiol ; 24(1): 206, 2024 Jun 10.
Artículo en Inglés | MEDLINE | ID: mdl-38858678

RESUMEN

BACKGROUND: Sugammadex is a pharmacologic agent that provides rapid reversal of neuromuscular blockade via encapsulation of the neuromuscular blocking agent (NMBA). The sugammadex-NMBA complex is primarily cleared through glomerular filtration from the kidney, raising the possibility that alterations in renal function could affect its elimination. In pediatric patients, the benefits of sugammadex have led to widespread utilization; however, there is limited information on its application in pediatric renal impairment. This study examined sugammadex use and postoperative outcomes in pediatric patients with severe chronic renal impairment at our quaternary pediatric referral hospital. METHODS: After IRB approval, we performed a retrospective analysis in pediatric patients with stage IV and V chronic kidney disease who received sugammadex from January 2017 to March 2022. Postoperative outcomes studied included new or increased respiratory requirement, unplanned intensive care unit (ICU) admission, postoperative pneumonia, anaphylaxis, and death within 48 h postoperatively, unplanned deferral of intraoperative extubation, and repeat administrations of NMBA reversal after leaving the operating room. RESULTS: The final cohort included 17 patients ranging from 8 months to 16 years old. One patient required new postoperative noninvasive ventilation on postoperative day 2, which was credited to hypervolemia. Another patient had bronchospasm intraoperatively resolving with medication, which could not definitively be associated sugammadex administration. There were no instances of deferred extubation, unplanned ICU or need for supplemental oxygen after tracheal extubation identified. CONCLUSION: No adverse effects directly attributable to sugammadex in pediatric patients with severe renal impairment were detected. There may be a role for utilization of sugammadex for neuromuscular reversal in this population.


Asunto(s)
Bloqueo Neuromuscular , Insuficiencia Renal Crónica , Sugammadex , Humanos , Sugammadex/administración & dosificación , Estudios Retrospectivos , Niño , Masculino , Femenino , Adolescente , Preescolar , Lactante , Bloqueo Neuromuscular/métodos , Complicaciones Posoperatorias , Fármacos Neuromusculares no Despolarizantes/administración & dosificación
4.
Br J Clin Pharmacol ; 90(7): 1667-1676, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38583490

RESUMEN

AIMS: Residual neuromuscular blockade has been linked to pulmonary complications in the postoperative period. This study aimed to determine whether sugammadex was associated with a lower risk of postoperative pulmonary complications (PPCs) compared with neostigmine. METHODS: This retrospective cohort study was conducted in a tertiary academic medical center. Patients ≥18 year of age undergoing noncardiac surgical procedures with general anesthesia and mechanical ventilation were enrolled between January 2019 and September 2021. We identified all patients receiving rocuronium and reversal with neostigmine or sugammadex via electronic medical record review. The primary endpoint was a composite of PPCs (including pneumonia, atelectasis, respiratory failure, pulmonary embolism, pleural effusion, or pneumothorax). The incidence of PPCs was compared using propensity score analysis. RESULTS: A total of 1786 patients were included in this study. Among these patients, 976 (54.6%) received neostigmine, and 810 (45.4%) received sugammadex. In the whole sample, PPCs occurred in 81 (4.54%) subjects (7.04% sugammadex vs. 2.46% neostigmine). Baseline covariates were well balanced between groups after overlap weighting. Patients in the sugammadex group had similar risk (overlap weighting OR: 0.75; 95% CI: 0.40 to 1.41) compared to neostigmine. The sensitivity analysis showed consistent results. In subgroup analysis, the interaction P-value for the reversal agents stratified by surgery duration was 0.011. CONCLUSION: There was no significant difference in the rate of PPCs when the neuromuscular blockade was reversed with sugammadex compared to neostigmine. Patients undergoing prolonged surgery may benefit from sugammadex, which needs to be further investigated.


Asunto(s)
Enfermedades Pulmonares , Neostigmina , Bloqueo Neuromuscular , Fármacos Neuromusculares no Despolarizantes , Complicaciones Posoperatorias , Rocuronio , Sugammadex , Humanos , Neostigmina/efectos adversos , Neostigmina/administración & dosificación , Sugammadex/efectos adversos , Sugammadex/administración & dosificación , Estudios Retrospectivos , Masculino , Femenino , Persona de Mediana Edad , Bloqueo Neuromuscular/efectos adversos , Bloqueo Neuromuscular/métodos , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/epidemiología , Complicaciones Posoperatorias/etiología , Anciano , Rocuronio/administración & dosificación , Rocuronio/efectos adversos , Fármacos Neuromusculares no Despolarizantes/efectos adversos , Fármacos Neuromusculares no Despolarizantes/administración & dosificación , Enfermedades Pulmonares/prevención & control , Adulto , Respiración Artificial/efectos adversos , Anestesia General/efectos adversos
5.
Paediatr Drugs ; 26(3): 347-353, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38512578

RESUMEN

BACKGROUND AND OBJECTIVE: Neuromuscular blocking agents are routinely used in laparoscopic surgery to optimize operative conditions. We compared the effect of a deep and moderate neuromuscular blockade (NMB) on surgical conditions and postoperative outcomes in children undergoing major laparoscopic surgery. METHODS: Sixty children aged 2-14 years scheduled to undergo major laparoscopic surgery were randomly allocated to deep (post-tetanic count 1-2 twitches) or moderate (train-of-four 1-2 twitches) NMB groups. The anesthesia was maintained with propofol and remifentanil, and the NMB was maintained with a rocuronium continuous infusion. At the end of the operation, the NMB were antagonized with sugammadex. The intra-abdominal pressure, airway pressure, Leiden Surgical Rating Scale, intraoperative hemodynamics, drug usages, duration of surgery, postoperative recovery time, pain, and complications were compared between the groups. RESULTS: The maximum and mean intra-abdominal pressure, the peak inspiratory pressure, and mean airway pressure were significantly lower in the deep NMB group than in the moderate NMB group (p < 0.001). The Leiden Surgical Rating Scale and the dosage of rocuronium were significantly higher in the deep NMB group than the moderate NMB group (p < 0.001). The intraoperative hemodynamics, duration of surgery, post-operative recovery time, pain, and the incidence rate of complications were not significantly different between the groups (p > 0.05). CONCLUSIONS: A deep NMB provided better operative conditions and similar recovery profiles compared with a moderate NMB as reversed with sugammadex in children undergoing major laparoscopic surgery. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry, No. ChiCTR2100053821.


Asunto(s)
Laparoscopía , Bloqueo Neuromuscular , Rocuronio , Humanos , Laparoscopía/métodos , Laparoscopía/efectos adversos , Niño , Bloqueo Neuromuscular/métodos , Masculino , Femenino , Preescolar , Adolescente , Rocuronio/administración & dosificación , Fármacos Neuromusculares no Despolarizantes/administración & dosificación , Periodo de Recuperación de la Anestesia , Remifentanilo/administración & dosificación , Propofol/administración & dosificación , Sugammadex/administración & dosificación
6.
Am Surg ; 90(6): 1618-1629, 2024 Jun.
Artículo en Inglés | MEDLINE | ID: mdl-38199669

RESUMEN

BACKGROUND: Postoperative gastrointestinal dysfunction (POGD) commonly occurs following gastrointestinal (GI) surgery and is associated with specific anesthetic agents. Cholinesterase inhibitors employed for reversing neuromuscular blockade have been implicated in development of POGD. Sugammadex, a novel reversal agent, is linked with reduced POGD. However, there is a lack of comprehensive comparative review between these agents regarding their impact on POGD following GI surgery. This study aims to systematically review the effects of sugammadex on POGD compared to cholinesterase inhibitors following GI surgery. METHODS: MEDLINE, EMBASE, and CENTRAL were searched as of July 2022 to identify articles comparing sugammadex with cholinesterase inhibitors in patients undergoing gastrointestinal surgery, specifically in relation to POGD. Secondary endpoints included length of hospital stay, readmission rates, pulmonary complications, and postoperative morbidity. RESULTS: From 198 citations, 2 randomized controlled trials (RCTs) and 3 retrospective cohorts with 717 patients receiving sugammadex and 812 patients receiving cholinesterase inhibitors were included. Significantly lower rates of prolonged postoperative ileus (OR .44, 95% CI .25-.77, P < .05, I2 = 56%, low certainty evidence) was observed with sugammadex. No significant difference in any other outcome was observed. Narrative review of readmission data demonstrated no significant difference. CONCLUSION: The use of sugammadex following gastrointestinal surgery is associated with significantly lower rates of prolonged postoperative ileus compared to cholinesterase inhibitors. However, these do not translate into a significant reduction in length of stay, morbidity, or postoperative nausea and vomiting. Results are limited by the numer of studies included and missing data, more robust RCTs are needed before recommendations can be made.


Asunto(s)
Inhibidores de la Colinesterasa , Procedimientos Quirúrgicos del Sistema Digestivo , Bloqueo Neuromuscular , Complicaciones Posoperatorias , Sugammadex , Humanos , Inhibidores de la Colinesterasa/uso terapéutico , Inhibidores de la Colinesterasa/efectos adversos , Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Enfermedades Gastrointestinales , Tiempo de Internación , Bloqueo Neuromuscular/efectos adversos , Bloqueo Neuromuscular/métodos , Sugammadex/administración & dosificación , Sugammadex/uso terapéutico
9.
Front Endocrinol (Lausanne) ; 13: 817476, 2022.
Artículo en Inglés | MEDLINE | ID: mdl-35222277

RESUMEN

Background: Neuromuscular blocking agents provide muscular relaxation for tracheal intubation and surgery. However, the degree of neuromuscular block may disturb neuromuscular transmission and lead to weak electromyography during intraoperative neuromonitoring. This study aimed to investigate a surgeon-friendly neuromuscular block degree titrated sugammadex protocol to maintain both intraoperative neuromonitoring quality and surgical relaxation during thyroid surgery. Methods: A total of 116 patients were enrolled into two groups and underwent elective thyroid surgery with intraoperative neuromonitoring. All patients followed a standardized intraoperative neuromonitoring protocol with continuous neuromuscular transmission monitoring and received 0.6 mg/kg rocuronium for tracheal intubation. Patients were allocated into two groups according to the degree of neuromuscular block when the anterior surface of the thyroid gland was exposed. The neuromuscular block degree was assessed by the train-of-four (TOF) count and ratio. Patients in group I received sugammadex 0.25 mg/kg for non-deep neuromuscular block degree (TOF count = 1~4). Patients in group II were administered sugammadex 0.5 mg/kg for deep neuromuscular block degree (TOF count = 0). The quality of the intraoperative neuromonitoring was measured using the V1 electromyography (EMG) amplitude. An amplitude less than 500 µV and greater than 500 µV was defined as weak and satisfactory, respectively. Results: The quality of the intraoperative neuromonitoring was not different between groups I and II (satisfactory/weak: 75/1 vs. 38/2, P = 0.14). The quality of surgical relaxation was acceptable after sugammadex injection and showed no difference between groups [55/76 (72.3%) in group I vs. 33/40 (82.5%) in group II, P = 0.23]. Conclusions: This surgeon-centered sugammadex protocol guided by neuromuscular block degree (0.5 mg/kg for deep block and 0.25 mg/kg for others) showed comparably high intraoperative neuromonitoring quality and adequate surgical relaxation. The results expanded the practicality of sugammadex for precise neuromuscular block management during monitored thyroidectomy.


Asunto(s)
Electromiografía , Monitoreo Intraoperatorio , Bloqueo Neuromuscular , Sugammadex/administración & dosificación , Glándula Tiroides/cirugía , Tiroidectomía , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Retrospectivos , Rocuronio/administración & dosificación , Cirujanos
10.
Clin Transl Sci ; 15(1): 234-243, 2022 01.
Artículo en Inglés | MEDLINE | ID: mdl-34435439

RESUMEN

Residual shallow neuromuscular block (NMB) is potentially harmful and contributes to critical respiratory events. Evidence for the optimal dose of sugammadex required to reverse vecuronium-induced shallow NMB is scarce. The aims of the present study were to find suitable doses of sugammadex and neostigmine to reverse a residual vecuronium-induced NMB from a time of flight (TOF) ratio of 0.3-0.9 and evaluate their safety and efficacy. In total, 121 patients aged 18-65 years were randomly assigned to 11 groups to receive placebo, sugammadex (doses of 0.125, 0.25, 0.5, 1.0, or 2.0 mg/kg), or neostigmine (doses of 10, 25, 40, 55, or 70 µg/kg). The reversal time of sugammadex and neostigmine to antagonize a vecuronium-induced shallow residual NMB (i.e., TOF ratio of 0.3) and related adverse reactions were recorded. Several statistical models were tested to find an appropriate statistical model to explore the suitable doses of sugammadex and neostigmine required to reverse a residual vecuronium-induced NMB. Based on a monoexponential model with the response variable on a logarithmic scale, sugammadex 0.56 mg/kg may be sufficient to reverse vecuronium-induced shallow residual NMB at a TOF ratio of 0.3 under anesthesia maintained with propofol. Neostigmine may not provide prompt and satisfactory antagonism as sugammadex, even in shallow NMB.


Asunto(s)
Retraso en el Despertar Posanestésico/inducido químicamente , Retraso en el Despertar Posanestésico/tratamiento farmacológico , Relación Dosis-Respuesta a Droga , Neostigmina/administración & dosificación , Neostigmina/farmacología , Sugammadex/administración & dosificación , Sugammadex/farmacología , Bromuro de Vecuronio/farmacología , Humanos
11.
Clin Pharmacol Drug Dev ; 11(3): 333-340, 2022 03.
Artículo en Inglés | MEDLINE | ID: mdl-34939354

RESUMEN

The main purpose of this study was to assess pharmacokinetic parameters (area under the plasma concentration-time curve from time 0 to infinity, area under the plasma concentration-time curve from time 0 to the last measurable concentration, maximum concentration, and apparent terminal half-life) after administration of 3 single intravenous (IV) doses of sugammadex to evaluate the safety and tolerability in healthy nonanesthetized subjects. This was an open-label, 3-period, nonrandomized, single-rising-dose study in 12 healthy Chinese subjects 18 to 45 years of age. In each period, every subject received a single IV dose of sugammadex in a fixed sequence (1, 2, and 4 mg/kg) under fasting conditions. There was a 3-day washout phase between dosing in each treatment period. In this study, a total of 11 (6 men and 5 women) Chinese subjects (with mean age of 25 ± 4.0 years; body weight, 64 ± 6 kg; height, 167 ± 6 cm; and body mass index, 22.9 ±1.2 kg/m2 ) received single doses of sugammadex 1, 2, and 4 mg/kg sequentially, with a 3-day washout phase between consecutive doses, and completed the study. The geometric mean maximum concentrations were 16.81, 30.99, and 60.55 µg/mL for sugammadex 1, 2, and 4 mg/kg, respectively. The median time to maximum concentration was 0.03 hour after bolus administration, and plasma sugammadex concentrations declined with a mean apparent terminal half-life of ≈1.7 hours across all 3 doses. Single-dose IV administration of sugammadex 1, 2, and 4 mg/kg was generally safe and well tolerated in healthy Chinese male and female subjects.


Asunto(s)
Pueblo Asiatico , Sugammadex , Adolescente , Adulto , Área Bajo la Curva , China , Femenino , Voluntarios Sanos , Humanos , Masculino , Persona de Mediana Edad , Sugammadex/administración & dosificación , Sugammadex/efectos adversos , Sugammadex/farmacocinética , Adulto Joven
12.
BMC Anesthesiol ; 21(1): 248, 2021 10 19.
Artículo en Inglés | MEDLINE | ID: mdl-34666673

RESUMEN

BACKGROUND: Sugammadex reverses neuromuscular blockade induced by steroidal relaxants. We compared the recovery for neuromuscular blockade reversal with sugammadex in children aged 1-12 years. METHODS: From August 2019 to August 2020, patients who received 2.0 mg·kg- 1 sugammadex for neuromuscular blockade reversal after surgery were recruited. The primary outcome was the time for the train-of-four ratio (TOFR) to recover to 0.9; secondary outcomes included the incidence of the TOFR < 0.9, extubation time, length of stay at the post-anesthesia care unit, and adverse events. Hemodynamic parameters before and 5 min after sugammadex administration and vital signs in the recovery room were also recorded. RESULTS: Eighty-six children were recruited (1 to < 3 years, n = 23; 3 to < 5 years, n = 33; 5 to ≤12 years, n = 30). Intergroup differences in the recovery of the TOFR to 0.9 were not statistically significant (F = 0.691, p = 0.504). Recurrence of the TOFR < 0.9 was not observed in any group. Five minutes after sugammadex administration, the heart rates of patients aged 3 to < 5 and 5 to ≤12 years were significantly lower than those at baseline (p < 0.05). Extubation time was similar in patients aged 1 to ≤12 years. Length of stay and end-tidal capnography at the post-anesthesia care unit as well as adverse events did not differ significantly. CONCLUSION: A moderate (TOF count two) rocuronium-induced neuromuscular blockade can be effectively and similarly reversed with sugammadex 2 mg·kg- 1 in Chinese children aged 1-12 years. TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR1900023715 (June 8, 2019).


Asunto(s)
Bloqueo Neuromuscular , Fármacos Neuromusculares no Despolarizantes/antagonistas & inhibidores , Sugammadex/administración & dosificación , Niño , Preescolar , Femenino , Frecuencia Cardíaca , Humanos , Lactante , Masculino , Fármacos Neuromusculares no Despolarizantes/administración & dosificación , Proyectos Piloto , Estudios Prospectivos , Rocuronio/administración & dosificación
13.
BMC Anesthesiol ; 21(1): 259, 2021 10 28.
Artículo en Inglés | MEDLINE | ID: mdl-34711192

RESUMEN

BACKGROUND: The aim of this randomized, double-blind trial was to evaluate the safety and tolerability profile, including cardiac safety, of sugammadex-mediated recovery from neuromuscular block in participants undergoing surgery who met the American Society of Anesthesiologists (ASA) Physical Class 3 or 4 criteria. Specifically, this study assessed the impact of sugammadex on cardiac adverse events (AEs) and other prespecified AEs of clinical interest. METHODS: Participants meeting ASA Class 3 and 4 criteria were stratified by ASA Class and NMBA (rocuronium or vecuronium) then randomized to one of the following: 1) Moderate neuromuscular block, sugammadex 2 mg/kg; 2) Moderate neuromuscular block, neostigmine and glycopyrrolate (neostigmine/glycopyrrolate); 3) Deep neuromuscular block, sugammadex 4 mg/kg; 4) Deep neuromuscular block, sugammadex 16 mg/kg (rocuronium only). Primary endpoints included incidences of treatment-emergent (TE) sinus bradycardia, TE sinus tachycardia and other TE cardiac arrhythmias. RESULTS: Of 344 participants randomized, 331 received treatment (61% male, BMI 28.5 ± 5.3 kg/m2, age 69 ± 11 years). Incidence of TE sinus bradycardia was significantly lower in the sugammadex 2 mg/kg group vs neostigmine/glycopyrrolate. The incidence of TE sinus tachycardia was significantly lower in the sugammadex 2 and 4 mg/kg groups vs neostigmine/glycopyrrolate. No significant differences in other TE cardiac arrythmias were seen between sugammadex groups and neostigmine/glycopyrrolate. There were no cases of adjudicated anaphylaxis or hypersensitivity reactions in this study. CONCLUSIONS: Compared with neostigmine/glycopyrrolate, incidence of TE sinus bradycardia was significantly lower with sugammadex 2 mg/kg and incidence of TE sinus tachycardia was significantly lower with sugammadex 2 mg/kg and 4 mg/kg. These results support the safety of sugammadex for reversing rocuronium- or vecuronium-induced moderate and deep neuromuscular block in ASA Class 3 or 4 participants. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT03346057 .


Asunto(s)
Bradicardia/inducido químicamente , Bloqueo Neuromuscular , Sugammadex/efectos adversos , Taquicardia/inducido químicamente , Anciano , Colinérgicos/administración & dosificación , Colinérgicos/efectos adversos , Método Doble Ciego , Femenino , Glicopirrolato/administración & dosificación , Glicopirrolato/efectos adversos , Humanos , Masculino , Neostigmina/administración & dosificación , Neostigmina/efectos adversos , Fármacos Neuromusculares no Despolarizantes/administración & dosificación , Rocuronio/administración & dosificación , Rocuronio/efectos adversos , Sugammadex/administración & dosificación , Bromuro de Vecuronio/administración & dosificación , Bromuro de Vecuronio/efectos adversos
14.
South Med J ; 114(10): 644-648, 2021 10.
Artículo en Inglés | MEDLINE | ID: mdl-34599343

RESUMEN

OBJECTIVE: This study blindly evaluated sugammadex compared with neostigmine on length of stay in the postanesthesia care unit (PACU). METHODS: Fifty patients undergoing elective laparoscopic cholecystectomy or abdominal wall hernia repair consented to receive either sugammadex (2 mg/kg) or neostigmine (0.07 mg/kg) for the reversal of rocuronium neuromuscular blockade. Reversal agents were administered during surgical closing, and the train of four was measured until a twitch ratio of T4:T1 ≥ 0.9 was obtained to signify a robust reversal. Postreversal outcomes also were measured during PACU stay. Aldrete scores, pain visual analog scale score, and nausea were measured during the PACU stay. RESULTS: Patients receiving sugammadex experienced a shorter PACU stay at the time of discharge than patients receiving neostigmine, by an average of 12 minutes (P < 0.05). CONCLUSIONS: Sugammadex patients had a significantly shorter PACU stay.


Asunto(s)
Procedimientos Quirúrgicos del Sistema Digestivo/efectos adversos , Neostigmina/efectos adversos , Tempo Operativo , Sala de Recuperación/estadística & datos numéricos , Sugammadex/efectos adversos , Adulto , Anciano , Procedimientos Quirúrgicos del Sistema Digestivo/métodos , Procedimientos Quirúrgicos del Sistema Digestivo/estadística & datos numéricos , Femenino , Florida , Humanos , Masculino , Persona de Mediana Edad , Neostigmina/administración & dosificación , Neostigmina/farmacología , Sala de Recuperación/organización & administración , Sugammadex/administración & dosificación , Sugammadex/farmacología
15.
Drug Des Devel Ther ; 15: 3893-3901, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-34548781

RESUMEN

High intra-abdominal pressure induced by artificial pneumoperitoneum can obviously impair respiratory and circulatory functions and has a negative effect on the prognosis of patients undergoing conventional and robot-assisted laparoscopic surgery. The application of deep neuromuscular blockade during the operation is reported to lower the intra-abdominal pressure and improve patients' outcome. However, concern lies in the risks of postoperative residual muscular paralysis with the use of deep neuromuscular blockade. Sugammadex, a specific antagonist for aminosteroids muscle relaxants, can effectively and rapidly reverse rocuronium and vecuronium induced neuromuscular blockade of different depths. Thus, sugammadex allows the ability to safeguard the application of deep neuromuscular blockade in laparoscopic operations and helps to alleviate the adverse complications associated with pneumoperitoneum. Here, we review the application of deep neuromuscular blockade in different laparoscopic surgeries and discuss the benefits and possible risks of sugammadex administration in the reversal of deep neuromuscular blockade in these operations.


Asunto(s)
Laparoscopía/métodos , Bloqueo Neuromuscular/métodos , Sugammadex/administración & dosificación , Humanos , Fármacos Neuromusculares no Despolarizantes/antagonistas & inhibidores , Fármacos Neuromusculares no Despolarizantes/farmacología , Procedimientos Quirúrgicos Robotizados/métodos , Rocuronio/antagonistas & inhibidores , Rocuronio/farmacología , Sugammadex/farmacología , Bromuro de Vecuronio/antagonistas & inhibidores , Bromuro de Vecuronio/farmacología
16.
Anesth Analg ; 132(6): 1666-1676, 2021 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-34032663

RESUMEN

BACKGROUND: Catheter-based endovascular neurointerventions require deep neuromuscular blocks during the procedure and rapid subsequent recovery of strength to facilitate neurological evaluation. We tested the primary hypothesis that sugammadex reverses deep neuromuscular blocks faster than neostigmine reverses moderate neuromuscular blocks. METHODS: Patients having catheter-based cerebral neurointerventional procedures were randomized to: (1) deep rocuronium neuromuscular block with posttetanic count 1 to 2 and 4-mg/kg sugammadex as the reversal agent or (2) moderate rocuronium neuromuscular block with train-of-four (TOF) count 1 during the procedure and neuromuscular reversal with 0.07-mg/kg neostigmine to a maximum of 5 mg. Recovery of diaphragmatic function was assessed by ultrasound at baseline before the procedure and 90 minutes thereafter. The primary outcome-time to reach a TOF ratio ≥0.9 after administration of the designated reversal agent-was analyzed with a log-rank test. Secondary outcomes included time to successful tracheal extubation and the difference between postoperative and preoperative diaphragmatic contraction speed and distance. RESULTS: Thirty-five patients were randomized to sugammadex and 33 to neostigmine. Baseline characteristics and surgical factors were well balanced. The median time to reach TOF ratio ≥0.9 was 3 minutes (95% confidence interval [CI], 2-3 minutes) in patients given sugammadex versus 8 minutes (95% CI, 6-10 minutes) in patients given neostigmine. Sugammadex was significantly faster by a median of 5 minutes (95% CI, 3-6 minutes; P < .001). However, times to tracheal extubation and diaphragmatic function at 90 minutes did not differ significantly. CONCLUSIONS: Sugammadex reversed deep rocuronium neuromuscular blocks considerably faster than neostigmine reversed moderate neuromuscular blocks. However, times to extubation did not differ significantly, apparently because extubation was largely determined by the time required for awaking from general anesthesia and because clinicians were willing to extubate before full neuromuscular recovery. Sugammadex may nonetheless be preferable to procedures that require a deep neuromuscular block and rapid recovery.


Asunto(s)
Neostigmina/administración & dosificación , Bloqueo Neuromuscular/métodos , Fármacos Neuromusculares no Despolarizantes/administración & dosificación , Procedimientos Neuroquirúrgicos/métodos , Rocuronio/administración & dosificación , Sugammadex/administración & dosificación , Adulto , Anciano , Catéteres , Inhibidores de la Colinesterasa/administración & dosificación , Femenino , Humanos , Masculino , Persona de Mediana Edad , Bloqueo Neuromuscular/efectos adversos , Procedimientos Neuroquirúrgicos/instrumentación
17.
BMC Anesthesiol ; 21(1): 154, 2021 05 20.
Artículo en Inglés | MEDLINE | ID: mdl-34016059

RESUMEN

BACKGROUND: Rocuronium-induced neuromuscular blockade can be quickly and completely reversed by administration of an optimal dose of sugammadex. Sugammadex antagonizes rocuronium-induced neuromuscular blockade by encapsulating rocuronium. Herein, we report a case of residual neuromuscular paralysis in which the recommended dose of sugammadex (4 mg·kg- 1) failed to antagonize a rocuronium-induced blockade. CASE PRESENTATION: A 71-year-old man (body mass index: 26.7 kg·m- 2) underwent endoscopic submucosal dissection of early-stage gastric cancer. He had no known factors that may have affected the effects of rocuronium and sugammadex. He received rocuronium (50 mg; 0.7 mg·kg- 1) for anesthesia induction. No additional rocuronium was administered during the 71-min procedure. Ninety-four minutes after rocuronium administration, neuromuscular monitoring showed 20 twitches in response to post-tetanic count stimulation. The train-of-four (TOF) ratio was not measurable despite sugammadex (280 mg; 4 mg/kg) administration, although four weak twitches in response to TOF stimulation appeared in 3 min. The TOF ratio became detectable following administration of an additional dose of sugammadex (120 mg; 1.7 mg·kg- 1), and it recovered to 107% 8 min after the second dose. The patient opened his eyes; moved his neck, arms, and limbs; and regained consciousness. The trachea was extubated and the patient was transferred to the ward. CONCLUSIONS: Neuromuscular monitoring should be used if a neuromuscular blockage agent is administered, even if the recommended dose of sugammadex is administered.


Asunto(s)
Bloqueo Neuromuscular/efectos adversos , Fármacos Neuromusculares no Despolarizantes/efectos adversos , Parálisis/inducido químicamente , Rocuronio/efectos adversos , Sugammadex/administración & dosificación , Anciano , Humanos , Masculino
18.
Laryngoscope ; 131(9): 2154-2159, 2021 09.
Artículo en Inglés | MEDLINE | ID: mdl-33720388

RESUMEN

OBJECTIVES/HYPOTHESIS: To compare effect of 1 and 2 mg/kg of sugammadex on the incidence of intraoperative bucking and intraoperative neuromonitoring (IONM) quality in thyroid surgery. STUDY DESIGN: Randomized controlled trial. METHODS: Patients qualified for thyroid surgery with IONM were eligible for this double-blind, randomized, controlled trial. After tracheal intubation with 0.6 mg/kg rocuronium, 1 or 2 mg/kg of sugammadex was administered to patients in group I or II, respectively. The quality of the IONM for the external branch of the superior laryngeal nerve (EBSLN) was evaluated (strong/intermediate/weak). The initial amplitude of electromyography for the vagus nerve (V1) and the recurrent laryngeal nerve (R1) were recorded. Intraoperative bucking movements was recorded. RESULTS: A total of 102 patients (51 in each group) completed the study. Time from sugammadex administration to initial checking for the EBSLN was not different between group I and II (25.0 ± 7.9 vs. 25.5 ± 9.0 minutes, P = .788). There was no difference in the neuromonitoring quality for the EBSLN between group I and II (strong/intermediate/weak: 46/5/0 vs. 50/1/0, P = .205). The amplitudes of V1 (1,086.3 ± 673.3 µV vs. 1,161.8 ± 727.5 µV, P = .588) and R1 (1,328.2 ± 934.1 µV vs. 1,410.5 ± 919.6 µV, P = .655) were comparable between the groups. Patients who experienced bucking were significantly fewer in the group I than the group II (13.7% vs. 35.3%, P = .020). CONCLUSION: A dose of 1 mg/kg sugammadex induced less bucking than 2 m/kg while providing comparable IONM quality during thyroid surgery. LEVEL OF EVIDENCE: 2 Laryngoscope, 131:2154-2159, 2021.


Asunto(s)
Cuidados Intraoperatorios/métodos , Monitoreo Intraoperatorio/instrumentación , Traumatismos del Nervio Laríngeo Recurrente/etiología , Sugammadex/efectos adversos , Glándula Tiroides/cirugía , Adulto , Anciano , Sistema Nervioso Central/efectos de los fármacos , Sistema Nervioso Central/fisiología , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Electromiografía/métodos , Estudios de Evaluación como Asunto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Nervio Laríngeo Recurrente/fisiología , Traumatismos del Nervio Laríngeo Recurrente/prevención & control , Síndrome de Dificultad Respiratoria/inducido químicamente , Síndrome de Dificultad Respiratoria/epidemiología , Sugammadex/administración & dosificación , Nervio Vago/fisiología
19.
Drug Des Devel Ther ; 15: 829-834, 2021.
Artículo en Inglés | MEDLINE | ID: mdl-33658764

RESUMEN

BACKGROUND: Sugammadex has been a revolutionary reversal of neuromuscular blockade. It is known to be highly efficient. However, a change in the coagulation profile is one of the most dangerous potential complications which is a concern for both surgeon and anesthetist. Bleeding may cause hypovolemic shock, hematoma, and so on. To investigate the effects of sugammadex on coagulation profiles in patients with thyroidectomy, we compared patients that were treated with either sugammadex or neostigmine. PATIENTS AND METHODS: Eighty patients with thyroid neoplasms undergoing thyroidectomy were randomly allocated to sugammadex group (group S) or neostigmine group (group N). Induction of anesthesia was preformed using propofol, sufentanil, and rocuronium. Group S received sugammadex 2.0mg/kg after trachea intubation, similarly Group N received neostigmine 40 µg/kg, for reversal of rocuronium-induced neuromuscular blockade. The intraoperative coagulation profiles were monitored after the rocuronium injection (T0), 10 minutes after reversal (T1) and 30 minutes after reversal (T2) by testing activated partial thromboplastin time (APTT), prothrombin time (PT), fibrinogen (FIB), thrombin time (TT), and TEG-Haemonetics. Amount of bleeding was recorded during perioperative period. RESULTS: There was no significant difference in the thromboelastogram, APTT, PT, FIB, or TT measurements at each time point in Group N. The reaction time (R time) and kinetics time (K time) of Group S in T1 were significantly longer than the corresponding times at T0 and T2, and the R times were significantly longer than those in Group N at the same time points (P<0.05). Additionally, in Group S, the APTT was prolonged in T1 and returned to normal in T2. CONCLUSION: The result showed that sugammadex provided transient efficacy in prolonging the coagulation parameters, while neostigmine did not change the coagulation profile.


Asunto(s)
Neostigmina/uso terapéutico , Bloqueo Neuromuscular , Sugammadex/uso terapéutico , Neoplasias de la Tiroides/tratamiento farmacológico , Adolescente , Adulto , Anciano , Pruebas de Coagulación Sanguínea , Femenino , Humanos , Masculino , Persona de Mediana Edad , Neostigmina/administración & dosificación , Sugammadex/administración & dosificación , Neoplasias de la Tiroides/cirugía , Tiroidectomía , Adulto Joven
20.
Anesth Analg ; 132(6): 1518-1526, 2021 06 01.
Artículo en Inglés | MEDLINE | ID: mdl-33543867

RESUMEN

BACKGROUND: Although the package insert clearly states that "the safety and efficacy of sugammadex in pediatric patients have not been established," we hypothesized that sugammadex is used widely in pediatric anesthetic practice supplanting neostigmine as the primary drug for antagonizing neuromuscular blockade (NMB). Additionally, we sought to identify the determinants by which pediatric anesthesiologists choose reversal agents and if and how they assess NMB in their practice. Finally, because of sugammadex's effects on hormonal contraception, we sought to determine whether pediatric anesthesiologists counseled postmenarchal patients on the need for additional or alternative forms of contraception and the risk of unintended pregnancy in the perioperative period. METHODS: We e-mailed a questionnaire to all 3245 members of the Society of Pediatric Anesthesia (SPA) requesting demographic data and attitudes regarding use of NMB agents, monitoring, and antagonism practices. To address low initial response rates and quantify nonresponse bias, we sent a shortened follow-up survey to a randomly selected subsample (n = 75) of SPA members who did not initially respond. Response differences between the 2 cohorts were determined. RESULTS: Initial questionnaire response rate was 13% (419 of 3245). Overall, 163 respondents (38.9%; 95% confidence interval [CI], 34.2-43.8) used sugammadex as their primary reversal agent, and 106 (25.2%; 95% CI, 21.2-30.0) used it exclusively. Respondents with ≤5 years of practice used sugammadex as their primary reversal agent more often than those with ≥6 years of practice (odds ratio [OR]: 2.08; 95% CI, 1.31-3.31; P = .001). This increased utilization remained after controlling for institutional restriction and practice type (adjusted OR [aOR]: 2.20; 95% CI, 1.38-3.54; P = .001). Only 40% of practitioners always assess NMB (train-of-four), and use was inversely correlated with years of practice (Spearman ρ = -0.11, P = .04). Anesthesiologists who primarily used sugammadex assess NMB less routinely (OR: 0.56; 95% CI, 0.34-0.90; P = .01). A slim majority (52.8%) used sugammadex for pediatric postmenarchal girls; those with less experience used it more commonly (P < .001). Thirty-eight percent did not discuss its effects on hormonal contraception with the patient and/or family, independent of anesthesiologist experience (P = .33) and practice location (P = .38). No significant differences were seen in demographics or practice responses between initial and follow-up survey respondents. CONCLUSIONS: Sugammadex is commonly used in pediatric anesthesia, particularly among anesthesiologists with fewer years of practice. Failure to warn postmenarchal adolescents of its consequences may result in unintended pregnancies. Finally, pediatric anesthesia training programs should emphasize objective monitoring of NMB, particularly with sugammadex use.


Asunto(s)
Monitoreo Intraoperatorio/normas , Bloqueo Neuromuscular/métodos , Fármacos Neuromusculares no Despolarizantes/administración & dosificación , Pediatría/normas , Sociedades Médicas/normas , Encuestas y Cuestionarios , Adulto , Anestesia/efectos adversos , Anestesia/métodos , Anestesiólogos/normas , Anestesiólogos/tendencias , Femenino , Humanos , Masculino , Persona de Mediana Edad , Monitoreo Intraoperatorio/métodos , Bloqueo Neuromuscular/efectos adversos , Pediatría/métodos , Sociedades Médicas/tendencias , Sugammadex/administración & dosificación
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