EUCTR2016-002323-28-BE
Active, not recruiting
Phase 1
Blood concentration and pharmacokinetic analysis of propofol following administration of single induction dose in small children
niversitair Ziekenhuis Brussel0 sites120 target enrollmentJune 3, 2016
ConditionsChildren scheduled for elective surgeryTherapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]
DrugsPropolipid
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Children scheduled for elective surgery
- Sponsor
- niversitair Ziekenhuis Brussel
- Enrollment
- 120
- Status
- Active, not recruiting
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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