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The Efficacy and Safety of Mivacurium in Pediatric Patients

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The Efficacy and Safety of Mivacurium in Pediatric Patients Zeng et al. BMC Anesthesiology (2017) 17:58 DOI 10.1186/s12871-017-0350-2 RESEARCH ARTICLE Open Access The efficacy and safety of mivacurium in pediatric patients Ruifeng Zeng1, Xiulan Liu1,5, Jing Zhang1, Ning Yin2,6, Jian Fei2, Shan Zhong2, Zhiyong Hu3, Miaofeng Hu3, Mazhong Zhang4,BoLi4, Jun Li1, Qingquan Lian1 and Wangning ShangGuan1* Abstract Background: Mivacurium is the shortest acting nondepolarizing muscle relaxant currently available; however, the effect of different dosages and injection times of intravenous mivacurium administration in children of different ages has rarely been reported. This study was aimed to evaluate the muscle relaxant effects and safety of different mivacurium dosages administered over different injection times in pediatric patients. Methods: Six hundred forty cases of pediatric patients, aged 2 m-14 years, ASA I or II, were divided into four groups (Groups A, B, C, D) according to the age class (2–12 m, 13–35 m, 3–6yearsand7–14 years) respectively, also each group were divided into four subgroups by induction dose (0.15, 0.2 mg/kg in 2–12 m age class; 0.2, 0.25 mg/kg in other three age classes), and mivacurium injection time (20 s, 40 s), totally 16 subgroups. Neuromuscular transmission was monitored with supramaximal train-of-four stimulation of the ulnar nerve. Radial artery blood (1 ml) was sampled to quantify plasma histamine concentrations before and 1, 4, and 7 min after mivacurium injection (P0, P1, P2 and P3). Results: Five hundred sixty-two cases completed the study. There were no demographic differences within the four groups. The onset time of 0.2 mg/kg groups in 2–12 m aged patients were shorter than those of 0.15 mg/kg groups (189 ± 64 s vs. 220 ± 73 s, 181 ± 60 s vs. 213 ± 71 s, P <0.05), and the recovery times were no statistical differences. The T1 25% recovery time of 0.2 mg/kg in 3–6 years aged patients was shorter than that of 0.25 mg/kg group (693 ± 188 s vs. 800 ± 206 s, P <0.05). The onset and recovery times of mivacurium were not different in 13–35 m and 7–14 years aged patients. The plasma concentrations of histamine at P0, P1, P2 and P3 were not different within four groups. Conclusions: The induction dose and injection time of mivacurium had mostly insignificant effects on onset and recovery times. The main exception to this was that in 2–12 m aged patients, increasing the dose of mivacurium from 0.15 to 0.2 mg/kg accelerated the onset time by about 30 s. Mivacurium produced no significant release of histamine in any age group at the doses studied. Trial registration: ClinicalTrials.gov Identifier-NCT02117401, July 14, 2014. (Retrospectively registered) Keywords: Mivacurium, Children, Neuromuscular block, Histamine, Efficacy Background recovery time in children is about 30% faster than in adults Mivacurium is a short-acting non-depolarizing neuro- [1]. In Germany, mivacurium is predominantly used for muscular blocker with a combination of the bisbenzylte- pediatric anesthesia [2]. Mivacurium has insignificant accu- trahydroisoquinolinium structure of atracurium and the mulation, which results in rapid spontaneous recovery enzymatically degradable ester linkage of suxamethonium, from the neuromuscular blockade and does not signifi- and is quickly hydrolyzed by plasma cholinesterase (pChe). cantly change cardiocirculatory parameters in pediatric pa- Mivacurium has been approved for use in children, and its tients [3, 4]. The use of reversal agent after administration of mivacurium in normal patients is not necessary due to the rapidity of spontaneous recovery [5]. In addition, miva- * Correspondence: [email protected] 1Department of Anesthesiology, Critical Care and Pain Medicine, The Second curium is considered to cause mild to moderate histamine Affiliated Hospital and Yuying Children’s Hospital of WenZhou Medical release, but its release is less in children as compared to University, 109 West Xueyuan Road, Wenzhou 325027, China adults [6]. Because of its rapid onset, short duration of Full list of author information is available at the end of the article © The Author(s). 2017 Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. Zeng et al. BMC Anesthesiology (2017) 17:58 Page 2 of 8 Table 1 Demographic data of group A (≥2, <12 months; n = 155) Table 3 Demographic data of group C (3–6 years, n = 141) Subgroups n Percentage Sex Body Induction Injecting Subgroups n Percentage Sex Body Induction Injecting in group (M/F) weight (kg) dose time (s) in group (M/F) weight (kg) dose time (s) A (%) (mg/kg) A (%) (mg/kg) Group 1 39 25 27/12 8.5 ± 2.4 0.15 20 Group 9 34 24 22/12 20.3 ± 5.2 0.20 20 Group 2 37 24 23/14 8.6 ± 2.2 0.15 40 Group 10 36 26 23/13 19.1 ± 5.9 0.20 40 Group 3 39 25 27/12 9.1 ± 2.4 0.20 20 Group 11 35 24 23/12 19.8 ± 6.5 0.25 20 Group 4 40 26 26/14 8.8 ± 2.0 0.20 40 Group 12 36 26 24/12 17.9 ± 5.5 0.25 40 There was no significant different for sex ratio and body weight among There was no significant different for sex ratio and body weight among four subgroups four subgroups action, lack of accumulation, short recovery, and relative electrolyte disorder; muscle relaxant administration lack of adverse effects, mivacurium was chosen for cases of during the previous 7 days; mivacurium allergy; and par- short duration and pediatric surgery. ticipation in any clinical subjects within the previous However, the effect of different dosages and injection 30 days before the study. times of intravenous mivacurium administration in dif- ferent aged children has rarely been reported. In this Interventions study, we hypothesized that different dosages and injec- Randomization was stratified independently in each hos- tion times of mivacurium as a bolus could have different pital by age class (2–12 months, 13–35 months, 3–6 effects on its pharmacodynamics and histamine release years and 7–14 years), induction dose (0.15 mg/kg miva- in different aged children. curium and 0.2 mg/kg mivacurium in 2–12 months age class, 0.2 mg/kg mivacurium and 0.25 mg/kg mivacur- Methods ium in other three age classes) and mivacurium injection Patient selection time (20 s, 40 s). All patients were divided into 4 groups A prospective randomized cohort study was conducted (Groups A, B, C, D) and 16 subgroups, summarized in among four children’s hospitals. Ethical approval for this Tables 1, 2, 3 and 4. Sealed envelopes containing patient study was provided by the Ethics Committee of the Sec- data were randomly provided to each study institution. ond Affiliated Hospital and Yuying Children’s Hospital Study personnel responsible for data collection were un- of Wenzhou Medical University (Chief centre, Number aware of which group each patient belonged to and were 2011-04-2). After written informed consent from parents allowed to enter the operating room only after adequate or guardians was obtained, 640 children, aged 2 months sedation had been administered to each child. to 14 years, physical status ASA I or II, scheduled to undergo elective general anesthesia with tracheal intub- Neuromuscular monitoring ation were enrolled in the study among four hospitals, Neuromuscular transmission was monitored with accel- 160 cases for each hospital. The planned surgical dur- eromyography (TOF WATCH SX). The ulnar nerve was ation was from 30 to 120 min. The exclusion criteria in- stimulated at the wrist by a train-of four (TOF) stimula- cluded: body mass index < 13.5 kg/m2 or > 31 kg/m2; tion (2 Hz, 0.2 ms) every 12 s and neuromuscular func- severe respiratory or cardiovascular system disease and tion was measured at the adductor pollicis. The four hepatic or renal insufficiency; history of neuromuscular fingers, excluding the thumb, were immobilized. Two disorder; airway abnormalities; abnormal plasma cholin- surface stimulating electrodes were put over the ulnar esterase activity or pseudo cholinesterase deficiency nerve at the wrist 2 cm apart, the negative electrode dis- (pChe test is one of preoperative routine tests in our tal to the positive one. The acceleration indicator was hospital); diabetes; serious acid–base imbalance or fixed to the volar aspect of the distal part of the thumb. Table 2 Demographic data of group B (13–35 months, n = 106) Table 4 Demographic data of group D (7–14 years, n = 160) Subgroups n Percentage Sex Body Induction Injecting Subgroups n Percentage Sex Body Induction Injecting in group (M/F) weight (kg) dose time (s) in group (M/F) weight (kg) dose time (s) A (%) (mg/kg) A (%) (mg/kg) Group 5 29 27 21/8 13.1 ± 6.1 0.20 20 Group 13 40 25 26/14 31.1 ± 11.3 0.20 20 Group 6 25 24 17/8 11.5 ± 2.1 0.20 40 Group 14 40 25 27/13 34.6 ± 17.2 0.20 40 Group 7 28 26 19/9 14.3 ± 7.2 0.25 20 Group 15 40 25 30/10 33.7 ± 11.8 0.25 20 Group 8 24 23 12/12 12.6 ± 3.1 0.25 40 Group 16 40 25 27/13 32.2 ± 13.1 0.25 40 There was no significant different for sex ratio and body weight among There was no significant different for sex ratio and body weight among four subgroups four subgroups Zeng et al.
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