E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Children scheduled for elective surgery |
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E.1.1.1 | Medical condition in easily understood language |
Children scheduled for elective surgery |
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E.1.1.2 | Therapeutic area | Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
-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
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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
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E.5 End points |
E.5.1 | 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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Up to 10 minutes after the administration of propofol |
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E.5.2 | Secondary end point(s) |
Pharmacokinetics of propofol in small children Adverse events in all participants |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Up to 7 days postoperative after the adminsistration of propofol |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Different dosage of same product |
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E.8.2.4 | Number of treatment arms in the trial | 6 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |