Efficacy and Safety of Ciprofol versus Propofol for Tracheal Intubation in Pediatric Patients Undergoing Laparoscopic

Jieze Pan1,2,3, Tianhao Zhong1,2,3, Yiwen Lv1,2,3

  • 1Department of Anesthesiology and Perioperative Medicine, The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University, Wenzhou, Zhejiang, People's Republic of China.

Insights

Ciprofol (0.782 mg/kg) is as effective as propofol for pediatric anesthesia during tracheal intubation, showing non-inferiority with fewer adverse events and less injection pain.

Area of Science:

  • Anesthesiology
  • Pediatric Anesthesia
  • Pharmacology

Background:

  • Ciprofol, a novel GABAA receptor agonist, presents a potential alternative for pediatric anesthesia.
  • Evaluating ciprofol's efficacy and safety for tracheal intubation in children is crucial.

Purpose of the Study:

  • Determine the effective dose 95 (ED95) of ciprofol for tracheal intubation in pediatric patients.
  • Compare the efficacy and safety of ciprofol versus propofol for pediatric anesthesia during laparoscopic hernia repair.

Main Methods:

  • A dose-finding phase determined the ED95 of ciprofol using a biased coin design up-and-down sequential method.
  • A non-inferiority phase randomly assigned 80 children to receive either ciprofol (0.782 mg/kg) or propofol (4 mg/kg) for induction.
  • Tracheal intubation conditions, adverse events, hemodynamics, and recovery times were assessed.

Main Results:

  • The ED95 of ciprofol for tracheal intubation was established at 0.782 mg/kg.
  • Ciprofol demonstrated non-inferiority to propofol, with excellent intubation conditions achieved in 95.0% of the ciprofol group versus 89.7% in the propofol group.
  • Adverse events were significantly lower with ciprofol (17.5%) compared to propofol (76.9%), notably reduced injection pain (2.5% vs. 38.5%).

Conclusions:

  • Ciprofol at 0.782 mg/kg is effective for pediatric tracheal intubation, achieving non-inferiority to propofol.
  • Ciprofol offers a favorable safety profile, including reduced injection pain and more stable hemodynamics compared to propofol.
  • Ciprofol represents a promising alternative anesthetic agent for pediatric surgical procedures.
Abstract

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