Odetola Folafoluwa O., Bhatt-Mehta Varsha, Zahraa Jihad, Moler Frank W., Custer Joseph R.
Department of Pediatrics and Communicable Diseases, Division of Pediatric Critical Care (FOO, JZ, FWM, JRC), and the College of Pharmacy and the Department of Pharmacy Services, University of Michigan Medical Center, Ann Arbor, MI.
Pediatr Crit Care Med. 2002 Jul;3(3):250-254. doi: 10.1097/00130478-200207000-00009.
To evaluate the safety and efficacy of cisatracurium besylate, a neuromuscular blocking agent in infants zero to 2 yrs of age. DESIGN: An open-label study to evaluate efficacy and safety of cisatracurium as a continuous infusion in infants. SETTING: A tertiary pediatric intensive care unit. PATIENTS: Eleven children, 0-2 yrs of age, requiring prolonged neuromuscular blockade. INTERVENTIONS: Cisatracurium besylate, 0.1 mg/kg, was administered as an intravenous bolus dose and repeated if necessary until a >90% neuromuscular blockade, as determined by train-of-four response, was achieved. Patients were allowed to recover to 90% blockade (I/IV twitch) after the initial bolus and were administered continuous infusion at 2 &mgr;g/kg/min. The continuous infusion rate was adjusted to maintain a train-of-four response of 0-I/IV, with an increase in the rate preceded by a bolus dose of cisatracurium besylate. An electromyographic monitor was used to measure recovery at the end of infusion, when possible. Heart rate and blood pressure were recorded after the initial bolus dose and after changes in infusion rates. Blood samples were drawn at steady-state during cisatracurium infusion at several different times during the study and at the end of infusion for measurement of plasma cisatracurium and laudanosine concentrations. MEASUREMENTS AND MAIN RESULTS: The mean infusion rate of cisatracurium besylate required to maintain train-of-four response of 0-I/iv was 5.4 +/- 3.0 &mgr;g/kg/min. The mean total duration of infusion was 64.5 +/- 36 hrs. Ten percent and complete neuromuscular recovery occurred at 26.6 +/- 10.4 and 74.8 +/- 32 mins, respectively, after discontinuation of infusion. Mean cisatracurium and laudanosine concentrations were 342.5 +/- 169 and 163.3 +/- 116 ng/mL, respectively. Four (37%) patients had undetectable (<5 ng/mL) cisatracurium concentrations at the time of 100% neuromuscular recovery (train-of-four response of IV/IV or no fade at 50 mA on the electromyogram). No significant hemodynamic changes were observed during treatment with cisatracurium besylate (p <.05). CONCLUSIONS: A longer period of recovery from neuromuscular blockade was observed compared with reports of older children. Recovery from neuromuscular blockade after long-term use was not associated with any adverse events in the immediate postinfusion period. Cisatracurium besylate is a safe and effective neuromuscular blocking agent for children 0-2 yrs of age.
评估苯磺顺阿曲库铵(一种神经肌肉阻滞剂)在0至2岁婴儿中的安全性和有效性。
一项开放标签研究,以评估苯磺顺阿曲库铵持续输注在婴儿中的有效性和安全性。
一家三级儿科重症监护病房。
11名0至2岁需要长期神经肌肉阻滞的儿童。
静脉推注苯磺顺阿曲库铵,剂量为0.1mg/kg,必要时重复给药,直至通过四个成串刺激反应确定达到>90%的神经肌肉阻滞。初始推注后允许患者恢复至90%的阻滞状态(I/IV颤搐),并以2μg/kg/min的速度进行持续输注。根据四个成串刺激反应维持在0-I/IV来调整持续输注速率,速率增加前先给予苯磺顺阿曲库铵推注剂量。尽可能在输注结束时使用肌电图监测仪测量恢复情况。在初始推注剂量后以及输注速率改变后记录心率和血压。在研究期间的几个不同时间点以及输注结束时采集血样,以测量血浆苯磺顺阿曲库铵和劳丹诺辛浓度。
维持四个成串刺激反应为0-I/IV所需的苯磺顺阿曲库铵平均输注速率为5.4±3.0μg/kg/min。平均总输注持续时间为64.5±36小时。输注停止后,分别在26.6±10.4分钟和74.8±32分钟时出现10%和完全神经肌肉恢复。苯磺顺阿曲库铵和劳丹诺辛的平均浓度分别为342.5±169和163.3±116ng/mL。4名(37%)患者在100%神经肌肉恢复时(四个成串刺激反应为IV/IV或肌电图上5毫安时无衰减)苯磺顺阿曲库铵浓度检测不到(<5ng/mL)。在使用苯磺顺阿曲库铵治疗期间未观察到明显的血流动力学变化(p<.05)。
与大龄儿童的报告相比,观察到神经肌肉阻滞恢复时间更长。长期使用后神经肌肉阻滞的恢复在输注后即刻未伴有任何不良事件。苯磺顺阿曲库铵是一种用于0至2岁儿童的安全有效的神经肌肉阻滞剂。