Time to Peak Effect of Propofol in Children (TPEPC)

University Hospital Basel

Status and phase: Completed; Phase 4

Conditions: Child; Propofol

Treatments: Drug: Propofol

Study type: Interventional

Funder types: Other

Identifiers

NCT03426462

UKBB-2017/032

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 1 to 13 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups

Age 1-6 years

Experimental group

Description:

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.

Treatment:

Drug: Propofol

Age 8-13 years

Experimental group

Description:

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.

Treatment:

Drug: Propofol