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首页> 外文期刊>Paediatric anaesthesia >A novel isotonic-balanced electrolyte solution with 1% glucose for intraoperative fluid therapy in children: results of a prospective multicentre observational post-authorization safety study (PASS).
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A novel isotonic-balanced electrolyte solution with 1% glucose for intraoperative fluid therapy in children: results of a prospective multicentre observational post-authorization safety study (PASS).

机译：一种用于儿童术中液体治疗的新型等渗平衡电解质溶液（含1％葡萄糖）：前瞻性多中心授权后安全性研究（PASS）的结果。

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BACKGROUND: The recommendations for intraoperative fluid therapy in children have been adapted from hypotonic to isotonic electrolyte solutions with lower glucose concentrations (1-2.5% instead of 5%) to avoid hyponatremia and hyperglycemia. OBJECTIVE: The objective of this prospective multicentre observational post-authorization safety study was to evaluate the intraoperative use of a novel isotonic-balanced electrolyte solution with 1% glucose (BS-G1) with a particular focus on changes in acid-base status, electrolyte and glucose concentrations. METHODS: Following local ethics committee approval, pediatric patients aged up to 4 years with an ASA risk score of I-III undergoing intraoperative administration of BS-G1 were enrolled. Patient demographics, the performed procedure, adverse drug reactions, hemodynamic data, and the results of blood gas analysis before and after infusion were documented with a focus on changes in acid-base status, electrolyte and glucose concentrations. RESULTS: In 107 patients (ASA I-III; age 16.2 +/- 15.4, range day of birth to 47.7 months; body weight 8.8 +/- 4.8, range 1.6-18.8 kg), the mean volume infused was 20 +/- 12.6 (range 3.6-83.3) ml.kg(-1) BS-G1. During the infusion, hemoglobin, hematocrit, anion gap, strong ion difference, and calcium decreased and chloride and glucose increased significantly within the physiologic range. All other measured parameters including sodium, bicarbonate, base excess, and lactate remained stable. Neither hypoglycemia (glucose <2.5 mmol.l(-1) ) nor hyperglycemia (glucose >10 mmol.l(-1) ) was documented after BS-G1 infusion. No adverse drug reactions were reported. CONCLUSION: The studied isotonic-balanced electrolyte solution with 1% glucose helps to avoid perioperative acid-base imbalance, hyponatremia, hyperglycemia, and ketoacidosis in infants and toddlers and may therefore enhance patient safety.
机译：背景：针对儿童术中液体疗法的建议已从低渗到等渗电解质溶液中降低了葡萄糖浓度（1-2.5％而不是5％），以避免低钠血症和高血糖症。目的：这项前瞻性多中心授权后观察性安全性研究的目的是评估术中使用含1％葡萄糖的新型等渗平衡电解质溶液（BS-G1），特别关注酸碱状态，电解质的变化和葡萄糖浓度。方法：经地方伦理委员会批准，对术中给予BS-G1的ASA风险评分为I-III的4岁以下小儿患者进行登记。记录患者的人口统计资料，所执行的程序，药物不良反应，血液动力学数据以及输注前后的血气分析结果，重点是酸碱状态，电解质和葡萄糖浓度的变化。结果：107例患者（ASA I-III;年龄16.2 +/- 15.4，出生日至47.7个月;体重8.8 +/- 4.8，范围1.6-18.8 kg），平均输注量为20 +/- 12.6（范围3.6-83.3）ml.kg（-1）BS-G1。输注期间，在生理范围内，血红蛋白，血细胞比容，阴离子间隙，强离子差和钙减少，氯和葡萄糖显着增加。所有其他测得的参数（包括碳酸钠，碳酸氢盐，碱过量和乳酸）保持稳定。 BS-G1输注后，既没有低血糖症（葡萄糖<2.5 mmol.l（-1））也没有高血糖症（葡萄糖> 10 mmol.l（-1））。没有药物不良反应的报道。结论：所研究的含1％葡萄糖的等渗平衡电解质溶液有助于避免婴幼儿围手术期酸碱失衡，低钠血症，高血糖症和酮症酸中毒，因此可以提高患者安全性。

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