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Population Pharmacokinetics of a single bolus of Ciprofol in Chinese pediatric patients
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  • Sicong Wang,
  • Yan Li,
  • Zhiyan Hu,
  • Longzhi Du,
  • Ying Wang,
  • Xiaoya Jiang,
  • Lujin Li,
  • Wangning Shangguan
Sicong Wang
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Yan Li
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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Longzhi Du
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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Ying Wang
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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Xiaoya Jiang
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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Lujin Li
Shanghai University of Traditional Chinese Medicine
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Wangning Shangguan
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Corresponding Author:[email protected]

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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.