Pharmacokinetics and pharmacodynamics of levobupivacaine during continuous caudal epidural analgesia in newborns - LEVO

Fakultní nemocnice v Motole0 个研究点目标入组 60 人开始时间: 2020年6月25日最近更新: 2023年7月18日

适应症

试验速览

暂无简介。

•Subjects fulfilling following criteria will be enrolled into the study during the 2 years time period.
•?Obtained informed consent of parent(s)/legal representative(s)
•?Age younger than 45th week of PMA
•?Previous or planned operation with great demand on POPM
•?Other diseases demanding great POPM (even without any need of surgery)
•?Vital functions of the patient will be stable and there will be no suspicion, that patient current condition might be worsen by insertion of c-CELA (every patient will be discussed with attending physician )
•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

•?Decline of informed consent by parent(s) legal representative
•?Age older than 45th week of PMA
•?Congenital malformation of caudal part of spine ( spina bifida oculta , meningocele, meningomyelocele)
•?Disease or congenital malformation significantly restricting liver functions (Elevation of liver enzymes more than twice above the physiological range of the corresponding PMA)
•?Disease or congenital malformation significantly restricting kidney functions (Elevation of urea and creatinine enzymes more than twice above the physiological range of the corresponding PMA)
•?Clinical condition, which doesn’t long-term POPM
•? Patients with proven withdrawal syndrome caused by opiate administration
•?High risk of bleeding during insertion (coagulopathy)
•?Severe anemia, which would lead to blood transfusion due to taking of blood samples

发起方

Fakultní nemocnice v Motole