Neuromuscular Nondepolarizing Agents

神经肌肉非去极化剂
  • 文章类型: Journal Article
    目的:为了确定强直刺激对达到T1高度稳定的时间的影响,通过加速肌电图四组(TOF)比率监测,60至80岁的患者。
    方法:随机化,prospective,单盲,2019年12月至2022年3月在巴西两家大学医院接受全麻择期手术的60至80岁患者的对照试验。该试验是根据赫尔辛基宣言的原则和神经肌肉阻断剂II的药效学研究中良好的临床研究实践指南进行的。参与者通过计算机生成的数字随机分配接受强直刺激(干预组,n=25)或不接受强直刺激(对照组,n=25)以在TOF比率监测上实现T1高度稳定。主要终点是评估强直刺激对达到T1高度稳定的时间的影响。我们还评估了单剂量0.6mg罗库溴铵对罗库溴铵起效时间和神经肌肉阻滞恢复时间的影响。kg-1自发恢复。
    结果:两组在达到T1身高稳定的时间上没有统计学上的显着差异(干预:4.3[2.0-8.0]分钟;对照组:5.8[2.0-10.5]分钟;p=0.202),神经肌肉阻滞剂的起效时间(干预:1.9[±0.7]分钟;对照:2.2[±1.0]分钟;p=0.219),或神经肌肉阻滞恢复时间至归一化TOF值为0.7(干预:106.1[±37.2]分钟;对照:91.7[±27.5]分钟;p=0.295),0.8(干预:114.3[±40.1]分钟;控制:97.8[±28.9]分钟;p=0.225),0.9(干预:126.5[±44.0]分钟;控制:106.9[±30.6]分钟;p=0.153),和1.0(干预:138.3[±43.4]分钟;对照:123.8[±43.5]分钟;p=0.425)。
    结论:这项研究的结果表明,在神经肌肉监测中使用强直刺激来缩短T1高度稳定时间的建议并没有改变T1抽搐的稳定时间或罗库溴铵对60至80岁患者的神经肌肉阻滞的药效学。
    OBJECTIVE: To determine the effect of tetanic stimulation on the time to achieve stabilization of the T1 height, by acceleromyography train-of-four (TOF) ratio monitoring, in patients aged 60 to 80 years.
    METHODS: Randomized, prospective, single-blind, controlled trial in patients aged 60 to 80 years undergoing elective surgery under general anesthesia in two university hospitals in Brazil between December 2019 and March 2022. This trial was performed in accordance with the principles of the Helsinki Declaration and the guidelines for good clinical research practice in pharmacodynamic studies of neuromuscular blocking agents II. Participants were randomly allocated by computer-generated numbers to receive tetanic stimulation (intervention group, n  =  25) or not receive tetanic stimulation (control group, n  =  25) to achieve T1 height stabilization on TOF ratio monitoring. The primary endpoint was to evaluate the effect of tetanic stimulation on the time to achieve stabilization of the T1 height. We also evaluated the effect on the onset time of rocuronium and time to recover from neuromuscular blockade with a single dose of rocuronium 0.6 mg.kg-1 with spontaneous recovery.
    RESULTS: There was no statistically significant difference between the groups in the time to T1 height stabilization (intervention: 4.3 [2.0-8.0] min; control: 5.8 [2.0-10.5] min; p  =  0.202), onset time of the neuromuscular blocking agent (intervention: 1.9 [±0.7] min; control: 2.2 [±1.0] min; p  =  0.219), or neuromuscular blockade recovery times to normalized TOF values of 0.7 (intervention: 106.1 [±37.2] min; control: 91.7 [±27.5] min; p  =  0.295), 0.8 (intervention: 114.3 [±40.1] min; control: 97.8 [±28.9] min; p  =  0.225), 0.9 (intervention: 126.5 [±44.0] min; control: 106.9 [±30.6] min; p  =  0.153), and 1.0 (intervention: 138.3 [±43.4] min; control: 123.8 [±43.5] min; p  =  0.425).
    CONCLUSIONS: The results of this study suggest that the recommendation to use tetanic stimulation to shorten the time to T1 height stabilization in neuromuscular monitoring did not alter the stabilization time of the T1 twitch or the pharmacodynamics of neuromuscular blockade with rocuronium in patients aged 60 to 80 years.
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  • 文章类型: Journal Article
    背景:深神经肌肉阻滞(d-NMB)是腹腔镜手术中脑腹膜的基本要求。然而,维持d-NMB直到手术完成,延迟了残留块的逆转。因此,当我们比较插管推注非去极化剂(阿曲库铵,维库溴铵)单独施用。这项研究旨在评估阿曲库铵-维库溴铵组合的协同作用是否增加d-NMB“腹腔镜”手术设置的作用时间。
    方法:48名患者(18-60岁,美国麻醉医师协会的身体状况-II/III,任何性别)接受腹腔镜胆囊切除术的患者随机分配接受维库溴铵(维库溴铵组,n=16)或阿曲库铵(阿曲库铵组,n=16)或维库溴铵-阿曲库铵组合(维库溴铵-阿曲库铵组合组,n=16),并分析了对作用持续时间(主要目标)的影响;作用开始,可逆性,腹腔镜胆囊切除术患者神经肌肉阻滞的插管条件(次要目标)的质量。
    结果:接受阿曲库铵-维库溴铵联合治疗(53.9±9.7分钟)与阿曲库铵单药(41.1±3.8分钟)或维库溴铵单药(43.5±9.2分钟)相比,神经肌肉阻滞的作用持续时间明显更长(P=0.000)。起效时间没有发现差异(维库溴铵[198.1±34.9秒],阿曲库铵[188.5±50.6秒],或阿曲库铵-维库溴铵组合[196.3±46.3秒][P=0.829]);肌肉松弛效应逆转的时间(维库溴铵[559.9±216.2秒],阿曲库铵[584.7±258.3秒],和阿曲库铵-维库溴铵组合[555.0±205.4秒][P=0.925]);和插管质量条件(维库溴铵组[9.6±1.3];阿曲库铵组[10.0±0.0];阿曲库铵-维库溴铵组[10.0±0.0][P=0.182])。
    结论:阿曲库铵-维库溴铵组合的协同作用导致d-NMB在腹腔镜胆囊切除术期间的作用持续时间增加,而不影响作用的开始,插管条件的质量,和肌肉松弛作用的逆转。
    BACKGROUND: Deep neuromuscular blockade (d-NMB) is an essential requirement for carboperitoneum during laparoscopy surgery. However, sustaining d-NMB till the completion of surgery delays the reversal of the residual block. Therefore, there is a merit in exploring the effect of synergistic vecuronium-atracurium combination on the duration-of-action of d-NMB during \"laparoscopic\" surgery when we compare intubating bolus non-depolarizers (atracurium, vecuronium) administered alone. This study aims to evaluate whether the synergistic effect atracurium-vecuronium combination increases duration-of-action of d-NMB \"laparoscopic\" surgery settings.
    METHODS: Forty-eight patients (18-60 years, American Society of Anesthesiologists physical status- II/III, either sex) undergoing laparoscopic cholecystectomy were randomly allocated to receive vecuronium (vecuronium group, n = 16) or atracurium (atracurium group, n = 16) or vecuroniumatr-acurium combination (vecuronium-atracurium combination group, n = 16) and analyzed for the effects on the duration-of-action (primary objective); onset-of-action, reversibility, and quality of intubating conditions (secondary objectives) profile of neuromuscular blockade in patients undergoing laparoscopic cholecystectomy.
    RESULTS: Duration-of-action of neuromuscular blockade was significantly longer in patients who received atracurium-vecuronium combination (53.9 ± 9.7 minutes) versus atracurium-alone (41.1 ± 3.8 minutes) or vecuronium-alone (43.5 ± 9.2 minutes) (P = 0.000). No difference was found for the time to onset-of-action (vecuronium [198.1 ± 34.9 seconds], atracurium [188.5 ± 50.6 seconds], or atracurium-vecuronium combination [196.3 ± 46.3 seconds] [P = 0.829]); time for the reversal of muscle relaxation effect (vecuronium [559.9 ± 216.2 seconds], atracurium [584.7 ± 258.3 seconds], and atracurium-vecuronium combination [555.0 ± 205.4 seconds] [P = 0.925]); and quality-of-intubating conditions (vecuronium group [9.6 ± 1.3]; atracurium group [10.0 ± 0.0]; atracurium-vecuronium group [10.0 ± 0.0] [P = 0.182]).
    CONCLUSIONS: The synergistic effect of the atracurium-vecuronium combination leads to an increased duration-of-action of d-NMB during laparoscopic cholecystectomy without impacting onset-of-action, quality of intubating conditions, and reversal of muscle relaxant effect.
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  • 文章类型: Journal Article
    目的:在腹腔镜手术中常规使用神经肌肉阻断剂以优化手术条件。我们比较了深度和中度神经肌肉阻滞(NMB)对接受腹腔镜大手术的儿童的手术条件和术后结局的影响。
    方法:将60名年龄在2-14岁接受腹腔镜大手术的儿童随机分为深度(强直后1-2次抽搐)或中度(4次1-2次抽搐)NMB组。用丙泊酚和瑞芬太尼维持麻醉,并且用罗库溴铵连续输注维持NMB。手术结束时,NMB被sugammadex拮抗。腹内压,气道压力,莱顿外科评定量表,术中血流动力学,药物用法,手术持续时间,术后恢复时间,疼痛,比较两组患者的并发症情况。
    结果:最大和平均腹内压,峰值吸气压力,深度NMB组的平均气道压力显著低于中度NMB组(p<0.001)。Leiden手术评定量表和罗库溴铵用量在深NMB组明显高于中度NMB组(p<0.001)。术中血流动力学,手术持续时间,术后恢复时间,疼痛,两组间并发症发生率差异无统计学意义(p>0.05)。
    结论:在接受大型腹腔镜手术的儿童中,与sugamadex逆转的中度NMB相比,深度NMB提供了更好的手术条件和相似的恢复情况。
    背景:中国临床试验注册中心,不。ChiCTR2100053821。
    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.
    BACKGROUND: Chinese Clinical Trial Registry, No. ChiCTR2100053821.
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  • 文章类型: Observational Study
    背景:深层神经肌肉阻滞(NMB)在各种外科手术中都有好处,然而,精确的定量神经肌肉监测对于其正确的维护和恢复至关重要。神经肌肉阻断剂的剂量取决于实际体重(ABW),但这因人而异。因此,这项研究假设,深度NMB的罗库溴铵需求量与生物电阻抗分析测得的肌肉质量比之间存在相关性。
    方法:本研究纳入90例接受腹腔镜手术的成年女性患者。使用身体组成分析仪评估肌肉和脂肪质量。深度封锁,定义为破伤风后计数为1-2,通过连续输注罗库溴铵来维持。主要结果涉及确定深度阻滞所需的罗库溴铵剂量与肌肉质量比之间的相关性。相反,次要结果包括评估罗库溴铵剂量之间的关系,脂肪质量比,和ABW。此外,我们调查了它们与罗库溴铵起效时间和深度阻断持续时间的关系。
    结果:肌肉质量比与保持深度阻滞所需的罗库溴铵剂量之间没有关系(r=0.059[95%CI=0.153-0.267],p=0.586)。脂肪质量比和ABW与罗库溴铵剂量无相关性,而罗库溴铵起效时间与肌肉质量比(r=0.327)和脂肪质量比(r=-0.302)呈正相关和负相关,分别。深度阻滞持续时间与任何评估变量均无相关性。
    结论:在肌肉质量比和实现深度阻滞所需的罗库溴铵剂量之间没有检测到相关性。
    BACKGROUND: Deep neuromuscular blockade (NMB) has benefits in various surgical procedures, however, precise quantitative neuromuscular monitoring is crucial for its proper maintenance and recovery. Neuromuscular blocking agent dosage relies on actual body weight (ABW), but this varies among individuals. Therefore, this study hypothesizes that there is a correlation between the rocuronium requirement for deep NMB and muscle mass ratio measured by bioelectric impedance analysis.
    METHODS: Ninety adult female patients undergoing laparoscopic operation were enrolled in this study. Muscle and fat masses were assessed using a body composition analyser. Deep NMB, defined as a post-tetanic count of 1-2, was maintained through the continuous infusion of rocuronium. The primary outcome involves determining the correlation between the rocuronium dose required for deep NMB and the muscle mass ratio. Conversely, secondary outcomes included assessing the relationship between the rocuronium dose for deep NMB and fat mass ratio, and ABW. Additionally, we investigated their relationship with rocuronium onset time and profound blockade duration.
    RESULTS: No relationship was observed between the muscle mass ratio and rocuronium dose required for maintaining deep NMB (r = 0.059 [95% CI = 0.153-0.267], p = 0.586). Fat mass ratio and ABW showed no correlation with the rocuronium dose, whereas rocuronium onset time was positively correlated with muscle mass ratio (r = 0.327) and negatively correlated with fat mass ratio (r = -0.302), respectively. Profound blockade duration showed no correlation with any of the assessed variables.
    CONCLUSIONS: No correlation was detected between muscle mass ratio and the rocuronium dose required to achieve deep NMB.
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  • 文章类型: Randomized Controlled Trial
    高体脂百分比患者的药效学可能与肥胖患者相似。这项随机对照临床试验观察了罗库溴铵对不同体脂百分比(PBFs)患者的影响。本研究纳入了在上海市总医院进行全身麻醉下择期泌尿外科或盆腔手术的54例患者;纳入了51例患者进行数据分析。PBF正常(<25%)的患者根据总体重(N-TBW,对照组)。PBF较高(≥25%)的患者根据总体重(H-TBW)计算单剂量的罗库溴铵。PBF和罗库溴铵较高的患者根据无脂质量(H-FFM)给药。一组四个(TOF)-观察加速度描记器用于测量罗库溴铵的作用。H-TBW(91.9±28.8s)的起效时间明显短于N-TBW和H-FFM(p=0.003)。H-TBW的临床持续时间和药理持续时间明显长于其他组(p=0.000和0.000);三组的TOF比值0.25-0.9时间差异有统计学意义(p=0.005)。三组间恢复时间(p=0.103)和恢复指数(p=0.159)差异无统计学意义。基于FFM的罗库溴铵对高PBF患者的影响与正常患者相似。基于TBW计算的单剂量罗库溴铵可能会缩短起效时间,延长临床和药理持续时间,并延长恢复时间。
    The pharmacodynamics in patients with high body fat percentage might be similar to those in obese patients. This randomised controlled clinical trial observed the effects of rocuronium in patients with different percent body fats (PBFs). Fifty-four patients who underwent elective urological or pelvic surgery under general anaesthesia at Shanghai General Hospital were included in the present study; 51 patients were included for data analysis. Patients with normal PBF (<25%) were given a single dose of rocuronium calculated based on total body weight (N-TBW, control group). Patients with a higher PBF (≥25%) were given a single dose of rocuronium calculated based on total body weight (H-TBW). Patients with higher PBF and rocuronium were dosed based on fat-free mass (H-FFM). A train of four (TOF)-Watch acceleromyography monitor was used to measure the effects of the rocuronium. H-TBW (91.9 ± 28.8 s) had significantly shorter onset time than N-TBW and H-FFM (p = 0.003). H-TBW had significantly longer clinical duration time and pharmacological duration time than the other groups (p = 0.000 and 0.000, respectively); the TOF ratio0.25-0.9 time was significantly different among the three groups (p = 0.005). There were no significant differences in the recovery time (p = 0.103) or recovery index (p = 0.159) among the three groups. The effects of rocuronium dosed based on FFM in patients with high PBFs are similar to those in normal patients. A single dose of rocuronium calculated based on TBW might shorten the onset time, prolong the clinical and pharmacological duration times, and prolong the recovery time.
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  • 文章类型: Clinical Trial, Phase III
    暂无摘要。
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  • 文章类型: Observational Study
    在快速序列插管(RSI)过程中,为肥胖患者提供足够的麻痹和适当的镇静是具有挑战性的。由于亲脂性低,药代动力学参数在罗库溴铵的给药中起重要作用。罗库溴铵可以基于理想体重(IBW)给药。目前的指南没有提供在肥胖情况下给药的建议。给药取决于临床医生基于总体重(TBW)或IBW的偏好。
    在这项研究中,我们进行了非劣效性分析,以比较插管条件,瘫痪的持续时间,在急诊科(ED)需要RSI的肥胖患者中,插管后新发心动过速或高血压的发生率。
    这是一个单中心,prospective,观察性研究。符合入选条件的是TBW≥30%IBW或体重指数≥30千克/平方米的成年患者,他们向ED提出要求使用罗库溴铵的RSI。罗库溴铵的剂量是根据插管医师的偏好进行的。医师完成了评估插管条件的调查。用于计算剂量的身高和体重,罗库溴铵的剂量,行政时间,记录肌肉功能恢复时间。评估的终点包括喉镜检查期间的视野分级,第一次成功,和瘫痪的持续时间。
    总共,纳入96例患者,54在TBW和42在IBW。与IBW组的0.71mg/kg相比,TBW组群平均接受1毫克/千克(mg/kg)。TBW组为68.5%,IBW组为73.8%。良好插管相对风险的非劣效性分析为1.12(P=0.12,[90%CI0.80-1.50])。
    非劣效性分析表明,与TBW剂量相比,IBW剂量提供了相似的最佳插管条件。但非劣效性比较未达到统计学意义.该研究无法显示IBW给药的统计学非劣效性。
    UNASSIGNED: Providing adequate paralysis and appropriate sedation is challenging in patients with obesity during rapid sequence intubation (RSI). Pharmacokinetic parameters play an important role in dosing of rocuronium due to low lipophilicity. Rocuronium may be dosed based on ideal body weight (IBW). Current guidelines do not offer recommendations for dosing in the setting of obesity. Dosing depends on clinician preference based on total body weight (TBW) or IBW.
    UNASSIGNED: In this study we performed non-inferiority analysis to compare the intubation conditions, duration of paralysis, and incidence of new-onset tachycardia or hypertension after intubation in obese patients requiring RSI in the emergency department (ED).
    UNASSIGNED: This was a single-center, prospective, observational study. Eligible for enrollment were adult patients with a TBW ≥30% IBW or body mass index ≥30 kilograms per meters squared who presented to the ED requiring RSI with the use of rocuronium. Rocuronium was dosed according to intubating physicians\' preference. Physicians completed a survey assessing intubation conditions. Height and weight used for the calculation of the dose, the dose of rocuronium, time of administration, and time of muscle function recovery were recorded. Endpoints assessed included grading of view during laryngoscopy, first-past success, and duration of paralysis.
    UNASSIGNED: In total, 96 patients were included, 54 in TBW and 42 in IBW. The TBW cohort received a mean of 1 milligram per kilogram (mg/kg) compared to 0.71 mg/kg in the IBW group. Excellent intubation conditions were observed in 68.5% in the TBW group and 73.8% in the IBW group. The non-inferiority analysis for relative risk of excellent intubation was 1.12 (P = 0.12, [90% CI 0.80-1.50]).
    UNASSIGNED: Non-inferiority analysis suggests that IBW dosing provides similar optimal intubation conditions when compared to TBW dosing, but the noninferiority comparison did not reach statistical significance. This study was unable to show statistical non-inferiority for IBW dosing.
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  • 文章类型: Randomized Controlled Trial
    背景:Sugammadex不建议用于严重肾功能损害的患者,但在许多其他人群中被证明在逆转神经肌肉阻滞方面优于新斯的明。这项研究的目的是确定用sugamadex逆转罗库溴铵诱导的神经肌肉阻滞与用新斯的明逆转顺式阿曲库铵诱导的神经肌肉阻滞是否会导致患者更快地恢复到4组比例(TOFR)≥90%严重肾功能不全。
    方法:我们进行了前瞻性,随机化,失明,在一家大型县医院进行的对照试验。共纳入49例患者。纳入标准包括年龄≥18岁的患者,美国麻醉医师协会(ASA)的身体状况III和IV,肌酐清除率<30mL/min,接受全身麻醉,预期手术持续时间≥2小时,需要神经肌肉阻滞。受试者接受顺式阿曲库铵0.2mg/kg或罗库溴铵0.6mg/kg进行麻醉诱导,以促进气管插管。受试者在手术过程中保持中度神经肌肉阻滞,并接受2mg/kgsugamadex或50µg/kg新斯的明和10µg/kg格隆溴铵用于逆转神经肌肉阻滞。神经肌肉监测用肌电图(TwitchView)进行,并且在施用逆转剂后每分钟记录TOFR。从给予神经肌肉逆转到患者达到TOFR≥90%的时间被记录为主要结果。
    结果:与新斯的明在14.8(±6.1)min时相比,sugammadex在3.5(±1.6)min时的TOFR≥90%的平均恢复时间明显更快(P<.0001;平均差异,11.3分钟;95%置信区间[CI],9.0-13.5分钟)。两组均无重大不良事件发生。
    结论:严重肾功能损害患者,与顺式阿曲库铵和新斯的明相比,使用罗库溴铵进行神经肌肉阻滞,然后用sugamadex逆转提供了明显更快的神经肌肉功能恢复,无重大不良影响。
    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.
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  • 文章类型: Multicenter Study
    目的:围手术期神经肌肉阻滞剂在药理学上被逆转,以减少与残余神经肌肉阻滞相关的并发症。抗胆碱酯酶的神经肌肉阻滞逆转(例如,新斯的明)需要共同施用抗胆碱能药(例如,格隆溴铵)减轻毒蕈碱活性;然而,sugammadex,缺乏胆碱能活性,不需要抗胆碱能联合给药。单机构研究发现,与sugammadex逆转相关的术后尿潴留发生率降低。这项研究使用了多中心数据库,以更好地了解神经肌肉阻滞逆转技术与术后尿潴留之间的关系。
    方法:利用大型医疗保健数据库进行回顾性队列研究。
    方法:非营利组织,农村和城市地区的非政府和社区以及教学医院和卫生系统。
    方法:61,898名匹配的成人住院患者和95,500名匹配的成人门诊患者。
    方法:用Sugamadex或新斯的明加格隆溴铵逆转神经肌肉阻滞。
    方法:神经肌肉阻滞逆转剂术后尿潴留的发生率以及神经肌肉阻滞逆转技术与术后尿潴留风险的独立关联。
    结果:与Sugamadex患者相比,新斯的明与格隆溴铵的术后尿潴留发生率高2倍(5.0%vs2.4%;0.9%vs0.4%门诊患者;两者均p<0.0001)。多变量逻辑回归确定,新斯的明逆转与术后尿潴留的更大风险独立相关(住院患者:比值比,2.20;95%置信区间,2.00至2.41;p<0.001;门诊患者:比值比,2.57;95%置信区间,2.13至3.10;p<0.001)。出院后2天内与尿retention留相关的访视在新斯的明逆转者中比住院患者中的sugammadex高出五倍(0.05%vs.0.01%,分别为;p=0.018)和门诊患者(0.5%与0.1%;p<0.0001)。
    结论:虽然本研究提示新斯的明逆转神经肌肉阻滞可增加术后尿潴留风险,需要更多的研究来充分了解这种关联.
    Perioperative neuromuscular blocking agents are pharmacologically reversed to minimize complications associated with residual neuromuscular block. Neuromuscular block reversal with anticholinesterases (e.g., neostigmine) require coadministration of an anticholinergic agent (e.g., glycopyrrolate) to mitigate muscarinic activity; however, sugammadex, devoid of cholinergic activity, does not require anticholinergic coadministration. Single-institution studies have found decreased incidence of post-operative urinary retention associated with sugammadex reversal. This study used a multicenter database to better understand the association between neuromuscular block reversal technique and post-operative urinary retention.
    Retrospective cohort study utilizing large healthcare database.
    Non-profit, non-governmental and community and teaching hospitals and health systems from rural and urban areas.
    61,898 matched adult inpatients and 95,500 matched adult outpatients.
    Neuromuscular block reversal with sugammadex or neostigmine plus glycopyrrolate.
    Incidence of post-operative urinary retention by neuromuscular block reversal agent and the independent association of neuromuscular block reversal technique and risk of post-operative urinary retention.
    The incidence of post-operative urinary retention was 2-fold greater among neostigmine with glycopyrrolate compared to sugammadex patients (5.0% vs 2.4% inpatients; 0.9% vs 0.4% outpatients; both p < 0.0001). Multivariable logistic regression identified reversal with neostigmine to be independently associated with greater risk of post-operative urinary retention (inpatients: odds ratio, 2.20; 95% confidence interval, 2.00 to 2.41; p < 0.001; outpatients: odds ratio, 2.57; 95% confidence interval, 2.13 to 3.10; p < 0.001). Post-operative urinary retention-related visits within 2 days following discharge were five-fold higher among those reversed with neostigmine than sugammadex among inpatients (0.05% vs. 0.01%, respectively; p = 0.018) and outpatients (0.5% vs. 0.1%; p < 0.0001).
    Though this study suggests that neuromuscular block reversal with neostigmine can increase post-operative urinary retention risk, additional studies are needed to fully understand the association.
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  • 文章类型: Randomized Controlled Trial
    背景:adamgammadex的初步临床试验,一种新型的基于环糊精的选择性逆转剂,已证明其在逆转罗库溴铵神经肌肉阻滞中的功效。
    方法:这个多中心,随机化,双盲,阳性对照,非劣效性III期临床试验比较了adamgammadex和sugammadex的疗效和安全性。我们随机分配了310名受试者,以在四人组(TOF)的第二次抽搐出现时接受adamgammadex(4mgkg-1)或sugammadex(2mgkg-1),并收集标准安全性数据.
    结果:对于主要结果,在adamgammadex组中,5分钟内TOF比率≥0.9的患者比例为98.7%,在sugammadex组中为100%,点估计和95%置信区间(CI)为1.3%(-4.6%,+1.3%);下限大于-10%的非劣效性边缘。对于关键的次要结果,从开始服用adamgammadex或sugammadex到TOF比率恢复到0.9的中位数(四分位数间)时间为2.25(1.75,2.75)min和1.75(1.50,2.00)min,分别。差异为0.50(95%CI:0.25,0.50);上限低于5分钟的非劣效性边缘。此外,在次要结局中未观察到较差的结果.与sugammadex相比,Adamgammadex的药物不良反应发生率较低(过敏反应,递归,心率下降,和喉痉挛;P=0.047)。
    结论:Adamgammadex不劣于sugammadex,与sugammadex相比,药物不良反应的发生率可能更低。Adamgammadex在其整体风险收益方面可能具有潜在优势。
    背景:中国临床试验注册中心,ChiCTR2000039525。2020年10月30日注册。https://www.chictr.org.cn/showproj.html?proj=56825。
    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.
    BACKGROUND: Chinese Clinical Trial Registry, ChiCTR2000039525. Registered October 30, 2020. https://www.chictr.org.cn/showproj.html?proj=56825.
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