Ciprofol versus Propofol for Emergence Agitation and Recovery Quality in Pediatric Dental Anesthesia: A Randomized Controlled Trial
TL;DR
Ciprofol was associated with significantly lower PAED scores, indicating reduced EA severity, along with faster emergence, improved recovery quality and higher parental satisfaction compared with propofol, suggesting that ciprofol may be an effective alternative to propofol in pediatric outpatient dental anesthesia.
Abstract
Purpose This prospective randomized controlled trial compared the effects of ciprofol versus propofol on emergence agitation severity, as measured by Pediatric Anesthesia Emergence Delirium (PAED) scores, and on postoperative recovery quality in children undergoing dental procedures under general anesthesia. Patients and Methods This single-center, prospective, double-blind trial enrolled 160 children aged 3–7 years (ASA I–II) scheduled for dental treatment under general anesthesia. Participants were randomized 1:1 to receive ciprofol (n=80) or propofol (n=80). The primary outcome was EA incidence, defined as a Pediatric Anesthesia Emergence Delirium (PAED) score >10 at 5 minutes after awakening. Secondary outcomes included PAED score, extubation and emergence times, postoperative pain (FLACC), respiratory complications, quality of recovery (QoR-15), and parental satisfaction. Results The incidence of EA was 3.8% (3/80) with ciprofol vs 7.5% (6/80) with propofol, with no statistically significant difference between groups (absolute difference: −3.75%; 95% CI: −12.22% to 4.00%; P=0.305). However, ciprofol significantly reduced total PAED scores [median 2.00 (IQR 2.00, 4.00) vs 5.00 (3.00, 7.00); P<0.001], with better scores across all five subscales (all P<0.01). Extubation time (3.83±0.96 vs 5.79±1.42 min; P<0.001) and emergence time (20.90±1.57 vs 22.77±3.28 min; P<0.001) were shorter with ciprofol. QoR-15 scores were higher (129.94±14.95 vs 121.97±16.22; P=0.002), and more parents reported being “very satisfied” (95.0% vs 85.0%; P=0.033) in the ciprofol group. Coughing incidence (5.0% vs 15.0%; P=0.035) and rescue sedation requirements (0.25±1.76 vs 2.33±8.38 mg; P=0.033) were also reduced. No significant difference was observed in FLACC pain scores (P=0.085). Conclusion While the incidence of emergence agitation did not differ significantly between groups, ciprofol was associated with significantly lower PAED scores, indicating reduced EA severity, along with faster emergence, improved recovery quality and higher parental satisfaction compared with propofol. These findings suggest that ciprofol may be an effective alternative to propofol in pediatric outpatient dental anesthesia, though the lack of a statistically significant difference in the primary outcome warrants cautious interpretation.