Population Pharmacokinetics of a single bolus of Ciprofol in Chinese
pediatric patients
Abstract
Aims: The study aimed to elucidate the population pharmacokinetics of
ciprofol in surgical pediatric patients and to establish a validated
dosing regimen for this demographic. Methods: In this study, 27 healthy
Chinese children aged 1 to 9, scheduled for elective urologic surgery,
received a 0.6 mg/kg bolus of ciprofol over 30 seconds. Thirteen
arterial blood samples were collected from each child for analysis. A
population pharmacokinetic analysis using nonlinear mixed-effects
modeling was conducted with intensive sampling data, and safety
assessments were performed throughout the trial. Results: Ciprofol’s
pharmacokinetics were best described by a three-compartment model, with
key parameters estimated as follows: clearance (CL) at 0.0313 L/min/kg,
central compartment volume (V1) at 0.506 L/kg, and peripheral volumes V2
and V3 at 0.225 L/kg and 1.34 L/kg, respectively. Intercompartmental
clearances were CL2 at 0.0278 L/min/kg and CL3 at 0.0199 L/min/kg.
Including blood urea nitrogen (BUN) as a covariate for V1 improved the
model statistically, but its effect on ciprofol exposure was minimal and
not clinically significant. Age and weight had no impact on ciprofol’s
pharmacokinetics. The study also reported that ciprofol was
well-tolerated, with no hemodynamic adverse events. Conclusions: In
pediatric patients, both CL and V1 of ciprofol are higher per kilogram
than in adults, necessitating a higher induction dose. A 0.6 mg/kg dose
in children aged 1 to 9 is expected to provide similar exposure without
adverse effects.