Effect-site targeted propofol for anaesthesia in children

A multicentre open study of the performance of an effect-site targeted infusion of propofol used for induction and maintenance of anaesthesia in children under 16 years

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN63387871

Enrollment

Registered

2011-02-22

Start date

2010-12-01

Completion date

Unknown

Last updated

2017-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

General anaesthesia Surgery Anaesthesia

Interventions

Patients will be recruited from suitable operating lists and after appropriate consent, will undergo induction and maintenance of general anaesthesia using the effect-site targeted infusion of propofo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. American Society of Anaesthesiologists (ASA) grade 1 and 2 healthy male and female children aged 1 to 12 years (inclusive) 2. Weight 6 - 60 kg 3. Elective surgery requiring general anaesthesia 4. Surgery or procedure of expected duration of at least 30 minutes 5. Written parental consent or child's consent if competent, for inclusion 6. Child appropriate for intravenous induction and maintenance of anaesthesia with propofol 7. Agreement to undergo intravenous induction of anaesthesia 8. No contraindication to application of topical local anaesthesia prior to cannulation

Exclusion criteria

Exclusion criteria: 1. Parental refusal or refusal of child if competent 2. Allergy to propofol or any constituent of propofol 3. Sensitivity to adhesive agents, as used in the Bispectral Index (BIS) measurement strip 4. Refusal of intravenous induction 5. Need for sedative premedication 6. Inadequate topical analgesia for intravenous cannulation 7. Inability to site intravenous cannula within two attempts

Design outcomes

Primary

Measure	Time frame
Performance of an effect-site target controlled infusion (TCI) pharmacokinetic model for children aged 1 to 12 years and weight 6 - 60 kg, as calculated from the four standard parameters described by Varvel et al. The performance error (PE) is calculated from the concentration of propofol measured in whole blood (Cmeas) and the concentration predicted by the software (Cpred) as follows: PE(%) = ((Cmeas-Cpred)/Cpred) x 100. Four standard measures of performance are derived from this value, namely bias, precision, divergence and wobble. These derived parameters estimate quantitatively whether the system over- or under-delivers propofol, and how this varies both between patients and for an individual patient over time.	—

Measure

Time frame

Performance of an effect-site target controlled infusion (TCI) pharmacokinetic model for children aged 1 to 12 years and weight 6 - 60 kg, as calculated from the four standard parameters described by Varvel et al. The performance error (PE) is calculated from the concentration of propofol measured in whole blood (Cmeas) and the concentration predicted by the software (Cpred) as follows: PE(%) = ((Cmeas-Cpred)/Cpred) x 100. Four standard measures of performance are derived from this value, namely bias, precision, divergence and wobble. These derived parameters estimate quantitatively whether the system over- or under-delivers propofol, and how this varies both between patients and for an individual patient over time.

—

Secondary

Measure	Time frame
1. Population pharmacokinetics of propofol in children aged 1 to 12 years using non-linear effects modelling (NONMEM). This allows the calculation of volume of distribution and clearance of propofol and potential relationships between these pharmacokinetic parameters and the variables of age, gender and weight to be explored. 2. Pharmacodynamic modelling, using bispectral index as a measure of depth of anaesthesia. This will allow direct estimation of the blood-brain equilibration rate-constant (keo) for propofol in this patient population. 3. Establish a safety profile for effect-site TCI propofol based on the pharmacodynamics of Jeleazcov et al by identifying the rate of adverse events associated with the use of effect-site targeted propofol infusion	—

Measure

Time frame

1. Population pharmacokinetics of propofol in children aged 1 to 12 years using non-linear effects modelling (NONMEM). This allows the calculation of volume of distribution and clearance of propofol and potential relationships between these pharmacokinetic parameters and the variables of age, gender and weight to be explored. 2. Pharmacodynamic modelling, using bispectral index as a measure of depth of anaesthesia. This will allow direct estimation of the blood-brain equilibration rate-constant (keo) for propofol in this patient population. 3. Establish a safety profile for effect-site TCI propofol based on the pharmacodynamics of Jeleazcov et al by identifying the rate of adverse events associated with the use of effect-site targeted propofol infusion

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026