Abstract
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.