Time to Peak Effect of Propofol in Children

Study Overview
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Brief Summary
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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.

Official Title
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Time to Peak Effect of Propofol in Children

Conditions
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Propofol, Child

Intervention / Treatment
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* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 13 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Age 1-6 years<br>Induction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes. The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups. | Drug: Propofol<br>* Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.<br>|
| Experimental: Age 8-13 years<br>Induction of anesthesia with propofol using infusion pumps that are programmed with a pharmacokinetic model to achieve a calculated plasma concentration of the drug; this is followed by two anesthetic deepening episodes. The target plasma concentrations achieved, as calculated by the programmed pump, is exactly the same in both age groups. | Drug: Propofol<br>* Induction of anesthesia and two further deepening episodes will be performed whilst recording the electroencephalogram.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to peak effect of a propofol bolus | 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 | up to 20 minutes from baseline until peak effect following second bolus administration | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacodynamic, Permutation Entropy, EEG