Efficacy and Safety of Ciprofol versus Propofol for Tracheal Intubation in Pediatric Patients Undergoing Laparoscopic Hernia Repair: An Assessor-Blinded Randomised Controlled Trial.

BACKGROUND

Ciprofol, a novel GABAA receptor agonist, might be an alternative for pediatric anesthesia. This study aimed to determine the ED95 of ciprofol, and compare its efficacy and safety with propofol for tracheal intubation in pediatric patients undergoing laparoscopic hernia repair.

PATIENTS AND

METHODS

Of 166 screened children, 120 were enrolled: 40 patients to dose-finding phase to determine the ED95 of ciprofol by biased coin design up-and-down sequential method, and the remaining 80 patients to non-inferiority comparison phase. 80 patients were randomly allocated in 1:1 ratio to receive ciprofol (0.782 mg/kg) or propofol (4 mg/kg) for induction, combined with fentanyl and cisatracurium. Primary outcome was proportion of patients who achieved an excellent grade for tracheal intubation conditions. Secondary outcomes included incidence of adverse events, hemodynamic parameters, loss of consciousness time, and PACU recovery time.

RESULTS

(1) ED95 of ciprofol for tracheal intubation in children undergoing laparoscopic hernia repair was 0.782 mg/kg (95% CI: 0.75-0.795 mg/kg). (2) An excellent grade for tracheal intubation conditions was achieved in 38 (95.0%) children in ciprofol group versus 35 (89.7%) children in propofol group in per-protocol analysis (rate difference 5.3%, 95% CI -4.14-14.73%). In intention-to-treat analysis, excellent grade rate in propofol group was 90.0% (36/40), with a rate difference of 5.0% (95% CI -4.1%-14.9%). Non-inferiority of ciprofol to propofol was confirmed in both analyses. Adverse events occurred in 7 (17.5%) children receiving ciprofol and 30 (76.9%) receiving propofol. Injection pain was significantly lower with ciprofol (2.5% vs. 38.5%).

CONCLUSION

In healthy, non-obese children aged 3-6 years undergoing laparoscopic hernia repair, ED95 of ciprofol for tracheal intubation was 0.782 mg/kg. Ciprofol (0.782 mg/kg) demonstrated non-inferiority to propofol (4 mg/kg) in excellent tracheal intubation conditions, with lower injection pain and more stable hemodynamics.