Assuntos
Anafilaxia , Sugammadex , gama-Ciclodextrinas , Humanos , Sugammadex/efeitos adversos , Anafilaxia/induzido quimicamente , Anafilaxia/diagnóstico , gama-Ciclodextrinas/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Feminino , Rocurônio/efeitos adversos , Rocurônio/administração & dosagem , Masculino , Hipersensibilidade a Drogas/diagnóstico , Hipersensibilidade a Drogas/etiologia , Pessoa de Meia-Idade , Androstanóis/efeitos adversosRESUMO
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.
Assuntos
Relação Dose-Resposta a Droga , Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , Sugammadex , Humanos , Sugammadex/administração & dosagem , Sugammadex/efeitos adversos , Sugammadex/farmacologia , Lactente , Bloqueio Neuromuscular/métodos , Bloqueio Neuromuscular/efeitos adversos , Recém-Nascido , Fatores Etários , Fármacos Neuromusculares não Despolarizantes/administração & dosagem , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/antagonistas & inibidores , Complicações Pós-Operatórias/prevenção & controle , Neostigmina/administração & dosagem , Neostigmina/efeitos adversos , Assistência Perioperatória/métodosRESUMO
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.
Assuntos
Pneumopatias , Neostigmina , Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , Complicações Pós-Operatórias , Rocurônio , Sugammadex , Humanos , Neostigmina/efeitos adversos , Neostigmina/administração & dosagem , Sugammadex/efeitos adversos , Sugammadex/administração & dosagem , Estudos Retrospectivos , Masculino , Feminino , Pessoa de Meia-Idade , Bloqueio Neuromuscular/efeitos adversos , Bloqueio Neuromuscular/métodos , Complicações Pós-Operatórias/prevenção & controle , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Idoso , Rocurônio/administração & dosagem , Rocurônio/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/administração & dosagem , Pneumopatias/prevenção & controle , Adulto , Respiração Artificial/efeitos adversos , Anestesia Geral/efeitos adversosAssuntos
Anafilaxia , Sugammadex , Humanos , Sugammadex/efeitos adversos , Anafilaxia/induzido quimicamente , Anafilaxia/diagnóstico , Anafilaxia/terapia , Anafilaxia/tratamento farmacológico , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Hipersensibilidade a Drogas/diagnóstico , Hipersensibilidade a Drogas/terapia , Hipersensibilidade a Drogas/etiologia , Bloqueio Neuromuscular/efeitos adversos , Fatores de RiscoRESUMO
Extravascular injection of neuromuscular blocking drugs (NMBDs) can cause a neuromuscular block because of systemic absorption. Currently, there are no guidelines available on managing extravasation of NMBDs. This article reviews the available literature on extravasation of NMBDs. Medline and Embase databases were searched for studies concerning the paravenous or subcutaneous injection of NMBDs. Nine articles were included consisting of seven case reports, one case series and one clinical trial. Rocuronium was used as primary NMBD in nine cases, vecuronium in two cases and pancuronium in one case. Although there exists significant heterogeneity between the reported information in the included studies, the majority of the case reports describe a slower onset, with a median delay of 20âmin and prolonged duration of the neuromuscular block. Nine patients had a residual neuromuscular block at the end of the surgery. Postoperative monitoring in the recovery room was prolonged (median time 4âh). Most studies suggest that the delay in NMBD onset and recovery is caused by the formation of a subcutaneous depot, from which the NMBD is slowly absorbed into the systemic circulation. According to the current literature, extravasation of NMBDs results in an unpredictable neuromuscular block. Strategies to prevent potentially harmful side effects, such as frequent train-of-four (TOF) monitoring, the use of NMBD reversal agents and prolonged length of stay in the postanaesthesia care unit (PACU), should be considered. This article suggests a clinical pathway that can be used after extravascular injection of NMBDs.
Assuntos
Bloqueio Neuromuscular , Bloqueadores Neuromusculares , Humanos , Bloqueadores Neuromusculares/administração & dosagem , Bloqueadores Neuromusculares/efeitos adversos , Bloqueio Neuromuscular/métodos , Bloqueio Neuromuscular/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/administração & dosagem , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Rocurônio/administração & dosagem , Extravasamento de Materiais Terapêuticos e Diagnósticos/etiologia , Período de Recuperação da Anestesia , Brometo de Vecurônio/administração & dosagemRESUMO
BACKGROUND: Sugammadex is not advised for patients with severe renal impairment, but has been shown in a variety of other populations to be superior to neostigmine for reversal of neuromuscular blockade. The objective of this study was to determine if reversal of rocuronium-induced neuromuscular blockade with sugammadex versus reversal of cisatracurium-induced neuromuscular blockade with neostigmine results in a faster return to a train-of-four ratio (TOFR) ≥90% in patients with severe renal impairment. METHODS: We conducted a prospective, randomized, blinded, controlled trial at a large county hospital. A total of 49 patients were enrolled. Inclusion criteria included patients age ≥18, American Society of Anesthesiologists (ASA) physical status III and IV, with a creatinine clearance <30 mL/min, undergoing general anesthesia with expected surgical duration ≥2 hours and necessitating neuromuscular blockade. Subjects received either cisatracurium 0.2 mg/kg or rocuronium 0.6 mg/kg for induction of anesthesia to facilitate tracheal intubation. Subjects were kept at moderate neuromuscular blockade during surgery and received either 2 mg/kg sugammadex or 50 µg/kg neostigmine with 10 µg/kg glycopyrrolate for reversal of neuromuscular blockade. Neuromuscular monitoring was performed with electromyography (TwitchView), and the TOFR was recorded every minute after administration of the reversal agent. The time from administration of neuromuscular reversal until the patient reached a TOFR ≥90% was recorded as the primary outcome. RESULTS: The mean time to recovery of TOFR ≥90% was significantly faster with sugammadex at 3.5 (±1.6) min compared with neostigmine at 14.8 (±6.1) min ( P < .0001; mean difference, 11.3 minutes; 95% confidence interval [CI], 9.0-13.5 minutes). There were no major adverse events in either group. CONCLUSIONS: In patients with severe renal impairment, neuromuscular blockade with rocuronium followed by reversal with sugammadex provides a significantly faster return of neuromuscular function compared to cisatracurium and neostigmine, without any major adverse effects.
Assuntos
Anestésicos , Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , Humanos , Inibidores da Colinesterase/efeitos adversos , Neostigmina/efeitos adversos , Bloqueio Neuromuscular/efeitos adversos , Bloqueio Neuromuscular/métodos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Estudos Prospectivos , Rocurônio , Sugammadex , AdultoRESUMO
Sugammadex is now in widespread use to reverse the neuromuscular blocking effects of rocuronium. Adverse effects from sugammadex are rare, but anaphylactic and cardiovascular reactions to the drug have been reported. In an attempt to reduce such side-effects, a modified gamma-cyclodextrin, adamgammadex, has been developed. Phase 3 clinical trials suggest that it is slightly less potent than sugammadex and has a non-inferior speed of onset. In a multicentre trial of 310 patients, there was a suggestion of a lower incidence of allergic responses and recurarisation after adamgammadex compared with sugammadex. The clinical implications of this study are discussed in this editorial.
Assuntos
Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , Humanos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Rocurônio , Sugammadex/efeitos adversos , Estudos Multicêntricos como Assunto , Ensaios Clínicos Fase III como AssuntoRESUMO
Postoperative urinary retention (POUR) is a well-known complication after gynecologic surgery. Our objective was to investigate whether the choice of pharmacologic agent for reversing neuromuscular blockade at the end of a hysterectomy is a risk factor for POUR. Among adult patients undergoing hysterectomy with general anesthesia from 2012 to 2017, those who received aminosteroid nondepolarizing neuromuscular agents followed by pharmacologic reversal were identified, and electronic health records were reviewed. The cohort was dichotomized into two groups by reversal agent: 1) sugammadex and 2) neostigmine with glycopyrrolate. The primary outcome, POUR, was defined as unplanned postoperative bladder recatheterization. A propensity-adjusted analysis was performed to investigate the association between POUR and reversal agent by using inverse probability of treatment weighting to adjust for potential confounders. We identified 1,974 patients, of whom 1,586 (80.3%) received neostigmine-glycopyrrolate and 388 (19.7%) received sugammadex for reversal of neuromuscular blockade. The frequency of POUR was 24.8% (393/1,586) after reversal with neostigmine-glycopyrrolate and 18.3% (71/388) with sugammadex. Results from the propensity-adjusted analysis showed that sugammadex was associated with a lower POUR risk than neostigmine-glycopyrrolate (odds ratio 0.53, 95% confidence interval [CI] 0.37 - 0.76, P < 0.001). A post hoc analysis of sugammadex recipients who received glycopyrrolate for another indication showed a higher POUR risk than among those who did not receive glycopyrrolate (odds ratio 1.86, 95% CI 1.07 - 3.22, P = 0.03). Use of sugammadex to reverse aminosteroid neuromuscular blocking agents is associated with decreased risk of POUR after hysterectomy. A potential mechanism is the omission of glycopyrrolate, which is coadministered with neostigmine to mitigate unwanted cholinergic effects.
Assuntos
Fármacos Neuromusculares não Despolarizantes , Retenção Urinária , Adulto , Humanos , Feminino , Sugammadex/uso terapêutico , Neostigmina/efeitos adversos , Glicopirrolato/farmacologia , Estudos de Coortes , Retenção Urinária/induzido quimicamente , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Complicações Pós-Operatórias/induzido quimicamente , HisterectomiaRESUMO
BACKGROUND: Residual neuromuscular block is associated with increased patient morbidity. Therefore prevention of residual neuromuscular block is an important component of general anaesthesia where neuromuscular blocking agents are used. Whereas sugammadex improves reversal based on neuromuscular twitch monitoring parameters, there have been no prospective, adequately powered definitive studies demonstrating that sugammadex is also associated with less patient morbidity. METHODS: We performed a systematic review of randomised trials comparing sugammadex with anticholinesterase-based reversal or placebo reversal that reported important patient outcomes beyond the postanaesthesia care unit. RESULTS: We identified 43 articles, including 5839 trial participants. Only one trial reported days alive and out of hospital to 30 days (DAOH-30), which showed that the number of DAOH-30 was similar in those allocated to sugammadex compared with neostigmine-based reversal (25 days [19-27] vs 24 days [21-27], median difference 0.00 [-2.15 to 2.15]). Pooled analyses of data from 16 trials showed an estimated odds ratio (OR) for postoperative pulmonary complications of 0.67 (95% confidence interval 0.47-0.95) with sugammadex use. Pooled analysis showed that pneumonia (eight trials OR 0.51 [0.24-1.01] with sugammadex use), hospital length of stay (23 trials, mean difference -0.31 [-0.84 to 0.22] with sugammadex use), and patient-reported quality of recovery (11 trials, varied depending on metric used) are similar in those allocated to sugammadex vs control. The difference seen in mortality (11 trials, OR 0.39 [0.15-1.01] with sugammadex use) would be considered to be clinically significant and warrants further investigation, however, the rarity of these events precludes drawing definitive conclusions. CONCLUSION: Although few trials reported on DAOH-30 or important patient outcomes, sugammadex is associated with a reduction in postoperative pulmonary complications, however, this might not translate to a difference in hospital length of stay, patient-reported quality of recovery, or mortality. CLINICAL TRIAL REGISTRATION: PROSPERO database (CRD42022325858).
Assuntos
Recuperação Demorada da Anestesia , Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , Humanos , Sugammadex , Recuperação Demorada da Anestesia/prevenção & controle , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Neostigmina/uso terapêutico , Inibidores da Colinesterase , Complicações Pós-Operatórias/prevenção & controle , Anestesia Geral/efeitos adversos , MorbidadeRESUMO
BACKGROUND: Preliminary clinical trials of adamgammadex, a new cyclodextrin-based selective reversal agent, have demonstrated its efficacy in reversing neuromuscular block by rocuronium. METHODS: This multicentre, randomised, double-blind, positive-controlled, non-inferiority phase III clinical trial compared the efficacy and safety of adamgammadex and sugammadex. We randomised 310 subjects to receive adamgammadex (4 mg kg-1) or sugammadex (2 mg kg-1) at reappearance of the second twitch of the train-of-four (TOF), and standard safety data were collected. RESULTS: For the primary outcome, the proportion of patients with TOF ratio ≥0.9 within 5 min was 98.7% in the adamgammadex group vs 100% in the sugammadex group, with a point estimate and 95% confidence interval (CI) of 1.3% (-4.6%, +1.3%); the lower limit was greater than the non-inferiority margin of -10%. For the key secondary outcome, the median (inter quartile range) time from the start of administration of adamgammadex or sugammadex to recovery of TOF ratio to 0.9 was 2.25 (1.75, 2.75) min and 1.75 (1.50, 2.00) min, respectively. The difference was 0.50 (95% CI: 0.25, 0.50); the upper limit was lower than the non-inferiority margin of 5 min. In addition, there were no inferior results observed in secondary outcomes. Adamgammadex had a lower incidence of adverse drug reactions compared with sugammadex (anaphylactic reaction, recurarisation, decreased heart rate, and laryngospasm; P=0.047). CONCLUSIONS: Adamgammadex was non-inferior to sugammadex with a possible lower incidence of adverse drug reactions compared with sugammadex. Adamgammadex may have a potential advantage in terms of its overall risk-benefit profile. CLINICAL TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR2000039525. Registered October 30, 2020. https://www.chictr.org.cn/showproj.html?proj=56825.
Assuntos
Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Humanos , Sugammadex/efeitos adversos , Rocurônio , Bloqueio Neuromuscular/métodos , gama-Ciclodextrinas/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Androstanóis/efeitos adversos , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos/etiologiaRESUMO
BACKGROUND: Sugammadex reverses the neuromuscular blockade induced by rocuronium and vecuronium and is approved by the U.S. Food and Drug Administration for use in patients aged over 2 years. There is, however, a paucity of data regarding its dosing profile in infants and children younger than 2 years. AIMS: The aim of this study was to assess the risk of recurarization, or re-paralysis, in children under 2 years of age to increase awareness on the importance of appropriate neuromuscular blocked monitoring and reversal. METHODS: All patients aged ≤24 months who underwent an operative procedure at a tertiary medical center between January 1, 2018, and December 31, 2021, and received both rocuronium for neuromuscular blockade and sugammadex for neuromuscular blockade reversal, were identified in the electronic medical record. Patients were excluded from analysis if they (1) received vecuronium, cisatracurium, atracurium, or succinylcholine for neuromuscular blockade, (2) received neostigmine for reversal, or (3) underwent more than one operation within 24 h. We performed a survival analysis of sugammadex redose using a Cox proportional hazards model. RESULTS: We reviewed 2923 records. Sugammadex was redosed in 123 (4.2%) cases. The median [IQR] time to redose was 7 [4-17] min, and the median [IQR] amount of redose administered was 2.74 [1.96-3.99] mg/kg. Increasing patient age (p < .01) and weight (p < .01) were associated with reduced hazard rate of sugammadex redose. For a patient of median weight, increasing age from 3 to 13 months was associated with a 53% risk reduction (HR: 0.47; 95% CI: 0.24-0.91). For a patient of median age, increasing weight from 4.7 to 9.2 kg was associated with 41% risk reduction (HR: 0.59; 95% CI: 0.32-1.07). We failed to detect any other associations. CONCLUSIONS: In this single-center, retrospective cohort study of pediatric surgery patients, there was an association between the hazard of sugammadex redose with both increased age and weight.
Assuntos
Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Lactente , Humanos , Criança , Pré-Escolar , Sugammadex , Rocurônio , Brometo de Vecurônio , gama-Ciclodextrinas/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Estudos Retrospectivos , Androstanóis , Fatores de Tempo , Bloqueio Neuromuscular/efeitos adversos , Bloqueio Neuromuscular/métodosRESUMO
The phenomena of residual curarisation and recurarisation after the use of long-acting non-depolarising neuromuscular blocking drugs such as tubocurarine and pancuronium were well recognised 60 years ago. But the incidence seemed to decline with the introduction of atracurium and vecuronium. However, recently there have been an increasing number of reports of residual and recurrent neuromuscular block. Some of these reports are a result of inappropriate doses of rocuronium, sugammadex or both, together with inadequate neuromuscular monitoring. We urge clinicians to review their practice to ensure the highest standards of clinical care when using neuromuscular blocking drugs and reversal agents. This includes the use of quantitative neuromuscular monitoring whenever neuromuscular blocking drugs are administered.
Assuntos
Bloqueio Neuromuscular , Bloqueadores Neuromusculares , Fármacos Neuromusculares não Despolarizantes , Humanos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Androstanóis/efeitos adversos , Rocurônio , Brometo de VecurônioRESUMO
AIM: Neuromuscular muscle relaxants are still indispensable for surgical procedures requiring general anesthesia, and the use of these agents may result in postoperative residual curarization. Sugammadex may offer a distinct advantage to pediatric patients where residual neuromuscular blockade may be poorly tolerated. Sugammadex is approved for use in adults and children over two years. This is the main reason why large-scale studies could not be conducted in the group of patients younger than two years old. This study aimed to evaluate the efficacy and safety of sugammadex for reversing deep rocuronium-induced neuromuscular blockade in children under two years of age. METHODS: Pediatric patients younger than two years of age who underwent neurosurgery under sevoflurane anesthesia were included in the study. Neuromuscular block was achieved by the administration of rocuronium. It was antagonized by the administration of 5 mg/kg sugammadex and evaluated using train-of-four (TOF). Primary outcome measure was the time from sugammadex administration to return of the TOF ratio to 0,9. Postoperative adverse events were also recorded. RESULTS: Two hundred eighty patients (10 day-24 months of age; 3-18 kg) were included in this study. Reversal of deep rocuronium-induced neuromuscular block with sugammadex was rapid in all patients. No residual curarization or recurarization was observed. No adverse events or hypersensitivity reactions were observed after administration of sugammadex. CONCLUSION: Reversal of rocuronium-induced deep neuromuscular block in infants was rapid and safe. Sugammadex provided safe extubation in patients younger than two years of age who had undergone neurosurgery. Research Fund. KEY WORDS: Neuromuscular blockade, Neuromuscular monitoring, Pediatrics, Sugammadex.
Assuntos
Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Adulto , Lactente , Humanos , Criança , Pré-Escolar , Rocurônio , Sugammadex/farmacologia , Bloqueio Neuromuscular/efeitos adversos , Bloqueio Neuromuscular/métodos , gama-Ciclodextrinas/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Androstanóis/efeitos adversos , Anestesia Geral , Período de Recuperação da AnestesiaRESUMO
There are few reports on rocuronium infiltration under general anesthesia. We report a case of suspected accidental rocuronium infiltration during anesthesia induction. A 25-year-old woman with autism spectrum disorder, intellectual disability, and epilepsy was scheduled for the extraction of 4 impacted third molars under general anesthesia. After induction with sevoflurane, an intravenous (IV) line was established in the left cephalic vein. Rocuronium was administered; however, subcutaneous swelling at the IV site was observed immediately. Spontaneous ventilations were maintained until additional rocuronium was administered via a new IV line. After heat pack application, the swelling disappeared 60 minutes after infiltration, and no tissue damage was observed. A strategy was developed to continue neuromuscular monitoring until recovery occurred. Acceleromyography was used, and the train-of-4 ratios at 99, 130, and 140 minutes after infiltration were 0.79, 0.91, and 1.0, respectively. Sugammadex was administered to prevent neuromuscular blockade recurrence. The patient was extubated once adequate return of muscle function and consciousness were observed. No neuromuscular block prolongation or recurrence were observed postoperatively. When rocuronium infiltration is suspected, it is important to eliminate swelling at the infiltration site and determine a management strategy based on neuromuscular monitoring.
Assuntos
Transtorno do Espectro Autista , Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Feminino , Humanos , Adulto , Rocurônio , gama-Ciclodextrinas/farmacologia , Androstanóis/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Anestesia Geral/efeitos adversos , Bloqueio Neuromuscular/efeitos adversosRESUMO
STUDY OBJECTIVE: The current study tested the hypothesis that magnesium sulfate after reversal with sugammadex causes recurarization. DESIGN: A single-center, prospective, randomized, double-blind, controlled trial. SETTING: Terciary care hospital in Rio de Janeiro, Brazil. PATIENTS: Included 60 patients undergoing for elective otolaryngological surgery. INTERVENTIONS: All patients received total intravenous anesthesia and a single dose of rocuronium (0.6 mg/kg). In 30 patients, the neuromuscular blockade was reversed with sugammadex (4 mg/kg) at the reappearance of one or two posttetanic counts (deep-blockade series). In 30 other patients, sugammadex (2 mg/kg) was administered at the reappearance of the second twitch of the train-of-four (moderate-blockade series). After the normalized train-of-four ratio recovered to ≥0.9, the patients in each series were randomized to receive intravenous magnesium sulfate (60 mg/kg) or placebo for 10 min. Neuromuscular function was measured by acceleromyography. MEASUREMENTS: The primary outcome was the number of patients who exhibited recurarization (normalized train-of-four ratio < 0.9). The secondary outcome was rescue with an additional dose of sugammadex after 60 min. MAIN RESULTS: In the deep-blockade series, a normalized train-of-four ratio < 0.9 occurred in 9/14 (64%) patients receiving magnesium sulfate and 1/14 (7%) receiving placebo, RR 9.0 (95% CI: 62-1.30), and (p = 0.002), with four rescues with sugammadex. In the moderate-blockade series, neuromuscular blockade recurred in 11/15 (73%) patients receiving magnesium sulfate and in 0/14 (0%) receiving placebo (p < 0.001), with two rescues. The absolute differences in recurarization were 57% and 73% in the deep-blockade and moderate-blockade, respectively. CONCLUSIONS: Single-dose magnesium sulfate led to a normalized train-of-four ratio < 0.9, 2 min after recovery from rocuronium-induced deep and moderate neuromuscular blockade using sugammadex. Additional sugammadex reversed prolonged recurarization.
Assuntos
Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Humanos , Sugammadex , Rocurônio , gama-Ciclodextrinas/efeitos adversos , Sulfato de Magnésio/efeitos adversos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Estudos Prospectivos , Androstanóis/efeitos adversos , Brasil , Bloqueio Neuromuscular/efeitos adversosRESUMO
BACKGROUND: Cranial nerve injury is an uncommon but significant complication of neck dissection. We examined the association between the use of intraoperative neuromuscular blockade and iatrogenic cranial nerve injury during neck dissection. METHODS: This was a single-center, retrospective, electronic health record review. Study inclusion criteria stipulated patients > 18 years who had ≥ 2 neck lymphatic levels dissected for malignancy under general anesthesia with a surgery date between 2008 - 2018. Use of neuromuscular blockade during neck dissection was the primary independent variable. This was defined as any use of rocuronium, cisatracurium, or vecuronium upon anesthesia induction without reversal with sugammadex prior to surgical incision. Univariate tests were used to compare variables between those patients with, and those without, iatrogenic cranial nerve injury. Multivariable logistic regression determined predictors of cranial nerve injury and was performed incorporating Firth's estimation given low prevalence of the primary outcome. RESULTS: Our cohort consisted of 925 distinct neck dissections performed in 897 patients. Neuromuscular blockade was used during 285 (30.8%) neck dissections. Fourteen instances (1.5% of surgical cases) of nerve injury were identified. On univariate logistic regression, use of neuromuscular blockade was not associated with iatrogenic cranial nerve injury (OR: 1.73, 95% CI: 0.62 - 4.86, p = 0.30). There remained no significant association on multivariable logistic regression controlling for patient age, sex, weight, ASA class, paralytic dose, history of diabetes, stroke, coronary artery disease, carotid atherosclerosis, myocardial infarction, and cardiac arrythmia (OR: 1.87, 95% CI: 0.63 - 5.51, p = 0.26). CONCLUSIONS: In this study, use of neuromuscular blockade intraoperatively during neck dissection was not associated with increased rates of iatrogenic cranial nerve injury. While this investigation provides early support for safe use of neuromuscular blockade during neck dissection, future investigation with greater power remains necessary.
Assuntos
Anestésicos , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Humanos , gama-Ciclodextrinas/farmacologia , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Estudos Retrospectivos , Sugammadex , Doença Iatrogênica , AndrostanóisRESUMO
BACKGROUND: Postoperative residual neuromuscular blockade (PRNB) is defined as an adductor pollicis train-of-four ratio (TOFR) <0.9. It is a common postoperative complication when nondepolarizing muscle relaxants are either not reversed or reversed with neostigmine. PRNB has been reported in 25% to 58% of patients who receive intermediate-acting nondepolarizing muscle relaxants, and it is associated with increased morbidity and decreased patient satisfaction. We conducted a prospective descriptive cohort study during the implementation of a practice guideline that included the selective use of sugammadex or neostigmine. The primary study aim of this pragmatic study was to estimate the incidence of PRNB at arrival to the postanesthesia care unit (PACU) when the practice guideline is followed. METHODS: We enrolled patients undergoing orthopedic or abdominal surgery requiring neuromuscular blockade. Rocuronium administration was guided by surgical requirements and based on ideal body weight, with dose reductions for women and/or age >55 years. Only qualitative monitoring was available to the anesthesia providers, and selection of sugammadex or neostigmine was guided by tactile assessments of the response to train-of-four (TOF) stimulation by a peripheral nerve stimulator. Neostigmine was administered if no fade was detected in the TOF response at the thumb. Deeper blocks were reversed with sugammadex. The prespecified primary and secondary end points were the incidence of PRNB at arrival to the PACU, defined as a normalized TOFR (nTOFR) < 0.9, and severe PRNB, defined as nTOFR <0.7 on arrival to the PACU. Anesthesia providers were blinded to all quantitative measurements made by research staff. RESULTS: Analysis included 163 patients, and 145 underwent orthopedic and 18 abdominal surgeries. Of the 163 patients, 92 (56%) were reversed with neostigmine and 71 (44%) with sugammadex. The overall incidence of PRNB at PACU arrival was 5 of 163 or 3% (95% confidence interval [CI], 1-7). The incidence of severe PRNB in PACU was 1% (95% CI, 0-4). Three of the 5 subjects with PRNB had TOFR <0.4 at time of reversal but were given neostigmine since anesthesia providers detected no fade by qualitative assessment. CONCLUSIONS: The use of a protocol that specifies rocuronium dosing and selective use of sugammadex versus neostigmine based on qualitative assessment of TOF count and fade allowed us to achieve an incidence of PRNB of 3% (95% CI, 1-7) at PACU arrival. Quantitative monitoring may be needed to further reduce this incidence.
Assuntos
Recuperação Demorada da Anestesia , Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , gama-Ciclodextrinas , Humanos , Feminino , Pessoa de Meia-Idade , Neostigmina/efeitos adversos , Sugammadex , Rocurônio , gama-Ciclodextrinas/efeitos adversos , Estudos de Coortes , Período de Recuperação da Anestesia , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Recuperação Demorada da Anestesia/diagnóstico , Bloqueio Neuromuscular/efeitos adversos , Bloqueio Neuromuscular/métodosRESUMO
STUDY OBJECTIVE: Residual neuromuscular block may lead to postoperative muscle weakness, inadequate oxygenation, and other pulmonary complications. Sugammadex may provide more rapid and effective restoration of neuromuscular function than neostigmine. We therefore tested the primary hypothesis that noncardiac surgical patients given sugammadex oxygenate better during initial recovery than those given neostigmine. Secondarily, we tested the hypothesis that patients given sugammadex have fewer pulmonary complications during hospitalization. DESIGN: Retrospective cohort analysis. SETTING: Postoperative recovery area of a tertiary care hospital. PATIENTS: Adults who had non-cardiothoracic surgery and were given either neostigmine or sugammadex. INTERVENTIONS: None. MEASUREMENTS: The primary outcome was the lowest SpO2/FiO2 ratio in the post-anesthesia care unit. The secondary outcome was a composite of pulmonary complications. MAIN RESULTS: Among 71,457 cases, 10,708 (15%) were given sugammadex and 60,749 (85%) received neostigmine. After propensity weighting, the mean minimum SpO2/FiO2 ratio was 301 ± 77 (SD) in patients given sugammadex and 303 ± 71 in those given neostigmine, yielding an estimated difference in means of -3.5 (95% confidence interval: -5.3, -1.7; P = 0.0002). 4.4% of patients given sugammadex and 3.6% of patients given neostigmine had postoperative pulmonary complications (P = 0.0005, number-needed-to-be-exposed =136; 95% CI: 83, 330), with the main contributing components being new bronchospasm or exacerbation of obstructive pulmonary disease. CONCLUSIONS: Postoperative minimum SpO2/FiO2 ratio during PACU admission was similar after reversal of neuromuscular block by sugammadex and neostigmine. Reversal with sugammadex was associated with more pulmonary complications, but most were minor and of little consequence.
Assuntos
Bloqueio Neuromuscular , Fármacos Neuromusculares não Despolarizantes , Adulto , Humanos , Neostigmina/efeitos adversos , Sugammadex/efeitos adversos , Bloqueio Neuromuscular/efeitos adversos , Estudos Retrospectivos , Fármacos Neuromusculares não Despolarizantes/efeitos adversos , Complicações Pós-Operatórias/epidemiologia , Complicações Pós-Operatórias/etiologia , Complicações Pós-Operatórias/prevenção & controle , Estudos de Coortes , Inibidores da Colinesterase/efeitos adversosRESUMO
Rocuronium is a neuromuscular blocking agent mainly used in anesthetic procedures. Two patients who died 53 and 76 days, respectively, after their last rocuronium exposure had low (0.002-0.007 mg/L) levels of the drug in femoral blood, urine and vitreous humor samples obtained at autopsy. In neither case, the cause of death was related to the exposure to rocuronium. Here, these two cases are presented and the implications of the findings discussed.