Blood concentration and pharmacokinetic analysis of propofol following administration of single induction dose in small children

niversitair Ziekenhuis Brussel0 个研究点目标入组 120 人开始时间: 2016年6月3日最近更新: 2024年8月12日

适应症

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•Normal- weight and overweight children aged 1 to 4 years with American Society of Anesthesiology (ASA) physical status classification I or II scheduled to undergo elective surgical procedures under general anaesthesia, according to clinical practice at Universitair Ziekenhuis Brussel (UZBrussel) will be eligible as potential participants.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 120
•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

•Children < 1 year and > 4 years of age
•Children < 10 kg body weight
•ASA physical status classification of = 3
•Known allergy to propofol, soy bean oil or egg lecithin
•Children with metabolic disorders
•Children with hemato- oncologic diseases
•Known renal disorders (as defined by 2x serum creatinine level for age and gender)
•Known liver disorders (as defined by 2x serum alanine aminotransferase (ALT) and aspartate aminotransferase (AST) for age)
•Children with epilepsy
•Children presenting for an urgent surgery
•Hemodynamic unstable children
•Ventilated children
•Children already receiving analgesics or sedatives prior to surgery
•Children receiving total parenteral nutrition or other solutions containing high load fat emulsions

发起方

niversitair Ziekenhuis Brussel