Ciprofol versus Propofol for General Anesthesia Induction in Major Orthopedic Surgery: Efficacy and Safety Analyses Pertaining to Anesthetic Parameters.

INTRODUCTION

Propofol is the standard agent for anesthesia induction but is frequently associated with injection-site pain and hemodynamic instability. Ciprofol (HSK3486), a novel GABAA receptor agonist, has emerged as a potential alternative. This study aimed to evaluate the efficacy and safety of ciprofol compared to propofol when induction of general anesthesia in patients undergoing major orthopedic surgery.

METHODS

In this study, 245 patients (ASA I-II) were allocated into ciprofol (CL, n = 107) or propofol (PL, n = 138) cohorts for major orthopedic surgery. All participants received midazolam (0.03 mg/kg), sufentanil (0.3 μg/kg), and preoxygenation. Induction was initiated with ciprofol (0.4 mg/kg over 30 s) or propofol (2 mg/kg). Successful induction required a modified Observer's Assessment of Alertness/Sedation (OAA/S) score ≤1 within 1 min. Persistent sedation failure necessitated a secondary dose (0.2 mg/kg of in ciprofol in CL cohort; PL: 1 mg/kg propofol in PL cohort). If failure continued, 0.5 mg/kg propofol served as rescue sedation for both groups. Post-intubation, anesthesia was maintained via sevoflurane in 50% oxygen.

RESULTS

Both cohorts achieved high induction success rates. One-minute post-administration, the median OAA/S score was 1 for both groups, though the PL cohort exhibited a higher frequency of deep sedation (OAA/S = 0) compared to the CL cohort (p < 0.001). The median time to successful induction was comparable between CL (49 s) and PL (48 s) (p = 0.136). However, the CL cohort demonstrated significantly greater hemodynamic stability, with a lower incidence of hypotension (9% vs. 28% in PL, p < 0.001). Furthermore, ciprofol significantly reduced injection-site pain, with a median VAS of 4 compared to 5 in the propofol group (p < 0.001), and a lower proportion of patients experiencing moderate-to-severe pain (p = 0.018). Bispectral index changes also favored the CL cohort (49.89 ± 3.15 vs. 40 ± 3.35, p < 0.001). Regarding intubation-related adverse events, the PL cohort experienced significantly higher rates of hypotension (28%) compared to the CL cohort (9%; p < 0.001).

CONCLUSION

Ciprofol is a highly effective alternative to propofol for anesthesia induction in major orthopedic surgery. It provides rapid onset and successful sedation while offering superior clinical advantages, specifically reduced injection-site pain and enhanced hemodynamic stability during the critical induction and intubation phases.