Children scheduled for elective surgery
Conditions
Interventions
Trade Name: Propolipid
Product Name: propofol
Pharmaceutical Form: Emulsion for injection/infusion
INN or Proposed INN: Propofol
CAS Number: 2078-54-8
Other descriptive name: PROPOFOL
Concentration un
Sponsors
Universitair Ziekenhuis Brussel
Eligibility
Sex/Gender
All
Inclusion 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
Exclusion criteria: Children 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Blood concentrations of propofol at various time points following administration of single induction dose in several subgroups of normal-weight and overweight children aged 1 to 4 years.;Secondary Objective: -Estimation of the most appropriate induction dose of propofol in small normal- weight and overweight children for the purpose of general anaesthesia and deep sedation which should correspond with a plasma propofol concentration of 4 to 6 µg/mL and 2 to 3 µg/mL respectively. -Time to achieve a significant peak plasma concentration for general anaesthesia and for deep sedation -Duration of clinically relevant peak plasma concentration -Determination of an association between blood concentration of propofol and induction dose calculation based on total body weight or lean body weight -Adverse events in all participants ;Primary end point(s): Correlation between the induction dose of propofol and the plasma propofol concentration of 4 to 6 µg/mL and 2 to 3 µg/mL, which mirrors the condition of general anesthesia and deep sedation respectively.;Timepoint(s) of evaluation of this end point: Up to 10 minutes after the administration of propofol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Pharmacokinetics of propofol in small children Adverse events in all participants;Timepoint(s) of evaluation of this end point: Up to 7 days postoperative after the adminsistration of propofol | — |
Countries
Belgium
Contacts
Public ContactData Nurse
Universitair Ziekenhuis Brussel
Outcome results
None listed