Intranasal dexmedetomidine: pilot pharmacokinetics / pharmacodynamics (PK/PD) study in a preterm population undergoing percutaneous central venous catheter placement - Pharmacokinetics of dexmedetomidine in preterm infants via the intranasal route

IRCCS MATERNO INFANTILE BURLO GAROFOLO0 个研究点目标入组 10 人开始时间: 2021年10月12日最近更新: 2022年3月14日

适应症

试验速览

暂无简介。

•1. Gestational age from 28 to 36 weeks with a minimum weight of 1 kg (50° percentile at 28 weeks of GA)
•2. Patent umbilical catheter already in place (venous or arterial)
•3. Need for a percutaneous venous catheter for nutritional and/or therapeutic purposes in elective conditions
•4. Consent to the study participation and to the off-label use of dexmedetomidine
•5. Drug therapies not included in the exclusion criteria
•Are the trial subjects under 18? yes
•Number of subjects for this age range:
•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

•1. Need for a percutaneous venous catheter in emergency conditions
•2. Cardiac instability (such as arrhythmias or significant cardiac dysfunctions), hemodynamically significant congenital heart disease
•3. Bradycardia at the time of enrolment with HR < 100
•4. Hypotension at the time of enrolment with mean BP less than GA
•5. Beta blocker or digoxin therapy or drugs acting on the atrio-ventricular node
•6. IVH 3-4
•7. Administration of sedative or anaesthetic drugs in the 8 hours prior to enrolment
•8. Any nasal obstruction that might impair the intranasal drug administration/absorption
•9. Craniofacial anomalies associated with difficulty in ventilation through a mask or intubation
•10. Liver disease characterised by AST > 100 U/L; ALT > 80 U/L; BD > 2 mg/dL or >20% of total bilirubin

发起方

IRCCS MATERNO INFANTILE BURLO GAROFOLO