Accuracy of the Kataria model for propofol anesthesia in children

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-001797-27-BE

Enrollment

Registered

2005-07-19

Start date

2005-08-01

Completion date

Unknown

Last updated

2014-10-07

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

Conditions

Dental and eye treatment under general anesthesia

Interventions

Product Name: Diprivan Pharmaceutical Form: Solution for infusion INN or Proposed INN: Propofol CAS Number: 2078-54-8 Concentration unit: % percent Concentration type: equal Concentration number: 1-

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: * 3-11 years * dental and eye treatment under general anesthesia Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: * allergy to any of the constituents of propofol or local anesthetics * previous adverse anesthetic experience * evidence of major pre-existing disease * suspected difficult airway * any concomitant disease or antibiotic treatment

Design outcomes

Primary

Measure	Time frame
Main Objective: Optimisatin of a 3-compartment pharmacokinetic model for propofol administration in children based on an existing PK model (Kataria). ;Secondary Objective: Modeling of an effect-site concentration to the PK model;Primary end point(s): Dose-response relationship for propofol in children aged between 3 and 11 years	—

Countries

Belgium

Outcome results

None listed

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