R_MHSUM in A Phase II Multicenter, Randomized, Double-Blind, Parallel Group, Dose-Ranging, Effect-Controlled Study to Determine the Pharmacokinetics and Pharmacodynamics of Sodium Nitroprusside (SNP) in Pediatric Subjects

Medical History Summary
Study Description
This was a randomized, double-blind, parallel group, dose-ranging, effect-controlled, multicenter study examining the effects of sodium nitroprusside (SNP) in pediatric patients requiring relative induced hypotension during a surgical or medical procedure. The study goals were to define the onset and offset of blood pressure lowering effects of SNP, to construct a dose-response model that defines the relationship between SNP infusion rate and changes in blood pressure in pediatric patients, and to assess the safety of SNP in pediatric patients requiring controlled reduction of blood pressure. Additional goals were to establish the starting and maximum infusion rates for optimum blood pressure control and a safe dosing regimen. A total of 211 participants were enrolled, and 203 included in the intent-to-treat population. Results indicate that a reasonable starting dose for SNP in this group would be 0.3 µg/kg/min. The clinician can then increase infusion rate to achieve the desired reduction in blood pressure. This population was comprised of pediatric patients requiring relative induced hypotension during a surgical or medical procedure.

医学病史摘要
研究概况
本研究为一项随机、双盲、平行对照、剂量探索、效应受控的多中心临床试验，旨在评估硝普钠（sodium nitroprusside, SNP）在需接受外科手术或诊疗操作并实施相对控制性低血压的儿科患者中的应用效果。研究目标包括：明确硝普钠降压效应的起效与消退时间；构建可反映儿科患者硝普钠输注速率与血压变化之间关联的剂量-反应模型；评估需实施控制性降压的儿科患者使用硝普钠的安全性。额外研究目标为确定实现最优血压控制的起始及最大输注速率，以及安全给药方案。本研究共计纳入211名受试者，其中203名被纳入意向治疗（intent-to-treat）人群。研究结果显示，该人群使用硝普钠的合理起始剂量为0.3 μg/kg/min，临床医师可后续调整输注速率以达到预期的降压目标。本研究人群为需在外科手术或诊疗操作中实施相对控制性低血压的儿科患者。