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

Phase 1

• Conditions: Children scheduled for elective surgery; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2016-002323-28-BE
• Lead Sponsor: niversitair Ziekenhuis Brussel

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-06-03
• Last Update Posted: 12 August 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified