Child, Propofol
Conditions
Keywords
Pharmacodynamic, Permutation Entropy, EEG
Brief summary
In order to determine the speed of onset of the anaesthetic propofol in children, investigators will compare the two age groups 1-6 years vs 8-13 years. The primary outcome measure is the time to peak effect of a bolus of proposal, which is measured by analysing the electroencephalogram by using the permutation entropy. Further pharmacodynamic modelling will enable investigators to quantify the difference with age in the hypnotic effect of propofol.
Interventions
DRUGPropofol
Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.
Sponsors
University Hospital, Basel, Switzerland
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Masking description
The analysis of the electroencephalogram will be blinded to the age of the participant.
Intervention model description
Age groups 1-6 years will be compared with 8-13 years whilst undergoing propofol anesthesia to detect whether there is indeed a difference in the speed of onset of the hypnotic effect of the drug.
Eligibility
Sex/Gender
ALL
Age
1 Years to 13 Years
Healthy volunteers
Yes
Inclusion criteria
* The study population will be healthy children in the ranges of 1-6 and 8-13 years of age having surgery with American Society of Anaesthesia (ASA) grades I-II (ie. no prior functional limitation due to comorbidities) that fulfil the following points: * parental written consent obtained at least a day prior to begin of the subject's study episode; and * the child is appropriate for induction and maintenance of anaesthesia with propofol.
Exclusion criteria
* Any significant subject co-morbidity (ASA III or IV); * Withdrawal of consent/assent at any point in the study; * Failure to cannulate a peripheral vein prior to induction after two attempts; * Any other reason making IV induction with propofol impossible; * Allergy to propofol (or its emulsion carrier), Eutectic Mixture of Local Anesthetics (EMLA) cream or Nitrous Oxide (N2O); * previous enrolment in the study; * Any anaesthetic problem that would take precedence over completion of the study protocol.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to peak effect of a propofol bolus | up to 20 minutes from baseline until peak effect following second bolus administration | This is the time from the start of the propofol bolus administration to the maximal suppression of the electroencephalogram; per subject two boli will be administered |
Countries
Switzerland
Outcome results
None listed