Dexmedetomidine pharmacokinetics-pharmacodynamicsin mechanically ventilated neonates with single-organ respiratory failure (NEODEX)

Ghent University Hospital0 个研究点开始时间: 2010年12月20日最近更新: 2017年8月21日

适应症

试验速览

暂无简介。

•- patient age less than 1 month (adaptive design:step-down strategy for age)
•- patients with single-organ respiratory failure in need for analgosedation (guidance : Comfort neo score>14 or Numeric Rating Scale (NRS) score Pain (P)/Comfort (C)>4)
•- patients admitted to the neonatal intensive care or cardiac intensive care unit
•- expected to require at least 20 h of mechanical ventilation
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 60
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- patients with neurologic conditions that prohibit an evaluation of adequate analgosedation
•- no arterial catheter in place at inclusion
•- patients who have received another investigational drug within 30 days
•- patients on continuous infusion with neuromuscular blockers
•- patients with a life expectancy <72h
•- patients with a known allergy to fentanyl
•- congenital or acquired heart block (grade 3)
•- sustained bradycardia
•- haemodynamically unstable patients (definition : Mean Arterial Pressure (MAP) lower than : gestational age (in weeks) – (absolute minimum for cardiac surgery patients: 40 mm Hg), eventually under dopamine infusion max. 15 mcg/kg/min and/or dobutamine infusion max. 15 mcg/kg/min) and/or epinephrine infusion: max 0,2 mcg/kg/min. More stringent criteria can be used based on an individual basis at the discretion of the attending neonatologist/intensivist.
•- patients with significant renal insufficiency (creatinine plasma level >1.5 mg/dl)
•- patients with significant hepatic insufficiency (as estimated by local investigators)
•- previous treatment with a2-adrenoreceptor agonist clonidine within 14 days
•- absence of parental consent

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