Prophylactic Efficacy of Cipepofol Against Postoperative Nausea and Vomiting in Moderate to High-Risk Patients of Apfel Score: A Multicenter, Randomized, and Parallel-Group Comparative Trial.

OBJECTIVE

This investigation systematically evaluated the antiemetic efficacy and safety of cipepofol for prophylaxis of postoperative nausea and vomiting (PONV) in surgical candidates with moderate to high Apfel risk.

METHODS

A prospective, multicenter, randomized, parallel-group comparative trial was conducted at 18 clinical centers (N=594). Participants aged 18-60 years (ASA physical status I-III) with 2-4 Apfel risk factors undergoing elective noncardiac surgery were randomized into three anesthesia maintenance cohorts after cipepofol induction: cipepofol monotherapy (0.8 mg/kg/h), sevoflurane (1.5-2.0%), and combination therapy (cipepofol 0.4 mg/kg/h plus sevoflurane 1.0%). The primary endpoint was the incidence of PONV at 24 h postoperatively. Secondary endpoints included the incidence of PONV at 48 h postoperatively and intraoperative hemodynamic stability.

RESULTS

Cipepofol monotherapy yielded a significantly lower 24-h PONV incidence (32.97% [95% CI, 27.1-39.2]) than sevoflurane (65.75% [59.4-71.6]; p<0.001). This difference persisted at 48 h (cipepofol: 35.68% [29.5-42.3]; sevoflurane: 69.06% [62.8-74.8]). A significantly lower proportion of patients required rescue antiemetic therapy in the cipepofol group than in the sevoflurane group within 48 h postoperatively (7.03% vs 16.02%, p=0.007). In addition, cipepofol was associated with a lower incidence of intraoperative hypotension than sevoflurane (9.73% vs 19.34%, p=0.009).

CONCLUSION

Compared with sevoflurane alone, cipepofol significantly reduced PONV incidence at 24 and 48 h after surgery, with more stable intraoperative hemodynamics.