Drug design, development and therapy · 2026
Comparison of the Efficacy of Ciprofol and Propofol for Rapid Sequence Induction and Intubation in Elective Non-Cardiac Surgery: A Prospective, Randomized, Non-Inferiority Trial.
Сравнительное исследованиеEquivalence TrialСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Lin Yimei, Wu Junmei, Wang Chengyu, Wu Jingyi, Liu Juanlan, Liu Manman, Miao Changhong, Liang Chao
Аннотация
BACKGROUND: Rapid sequence induction and intubation (RSII) requires an agent that provides excellent intubating conditions with minimal hemodynamic disturbance. Propofol is standard but often causes hypotension. We compared the novel agent ciprofol with propofol for RSII in adult patients scheduled for elective non-cardiac surgery.
METHODS: In this prospective, randomized, double-blind, non-inferiority trial, 170 adult patients scheduled for elective non-cardiac surgery were allocated to receive intravenous ciprofol (0.4 mg/kg, n = 85) or propofol (2.0 mg/kg, n = 85) for induction, with remifentanil and rocuronium. The non-inferiority margin was set at -10% for the primary outcome. The primary outcome was the proportion of patients with excellent intubation conditions (Viby-Mogensen scale). Secondary outcomes included incidence of hypotension, induction success rate, time to loss of consciousness (LOC), bispectral index (BIS) values, and pain on injection.
RESULTS: Excellent intubation conditions were achieved in 96.5% (82/85) of the ciprofol group and 95.3% (81/85) of the propofol group (difference 1.2%, 95% CI: -4.4% to 6.7%). The lower limit of the 95% CI exceeded the prespecified non-inferiority margin of -10%. The per-protocol analysis confirmed non-inferiority (difference 1.2%, 95% CI -4.2% to 6.7%). The incidence of post-induction hypotension was significantly lower in the ciprofol group (15.3% vs 43.5%; RR 0.35, 95% CI 0.20 to 0.61; P < 0.001). No patient reported injection pain with ciprofol, compared to 68.2% with propofol (P < 0.001). Time to LOC and induction success rates were similar between groups.
CONCLUSION: In adult patients undergoing elective non-cardiac surgery under a standardized RSI protocol, ciprofol 0.4 mg/kg provided intubating conditions non-inferior to propofol 2.0 mg/kg and was associated with less post-induction hypotension and injection pain. Further studies are needed in emergency, critically ill, and high-risk RSI populations.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2500095742).
METHODS: In this prospective, randomized, double-blind, non-inferiority trial, 170 adult patients scheduled for elective non-cardiac surgery were allocated to receive intravenous ciprofol (0.4 mg/kg, n = 85) or propofol (2.0 mg/kg, n = 85) for induction, with remifentanil and rocuronium. The non-inferiority margin was set at -10% for the primary outcome. The primary outcome was the proportion of patients with excellent intubation conditions (Viby-Mogensen scale). Secondary outcomes included incidence of hypotension, induction success rate, time to loss of consciousness (LOC), bispectral index (BIS) values, and pain on injection.
RESULTS: Excellent intubation conditions were achieved in 96.5% (82/85) of the ciprofol group and 95.3% (81/85) of the propofol group (difference 1.2%, 95% CI: -4.4% to 6.7%). The lower limit of the 95% CI exceeded the prespecified non-inferiority margin of -10%. The per-protocol analysis confirmed non-inferiority (difference 1.2%, 95% CI -4.2% to 6.7%). The incidence of post-induction hypotension was significantly lower in the ciprofol group (15.3% vs 43.5%; RR 0.35, 95% CI 0.20 to 0.61; P < 0.001). No patient reported injection pain with ciprofol, compared to 68.2% with propofol (P < 0.001). Time to LOC and induction success rates were similar between groups.
CONCLUSION: In adult patients undergoing elective non-cardiac surgery under a standardized RSI protocol, ciprofol 0.4 mg/kg provided intubating conditions non-inferior to propofol 2.0 mg/kg and was associated with less post-induction hypotension and injection pain. Further studies are needed in emergency, critically ill, and high-risk RSI populations.
TRIAL REGISTRATION: Chinese Clinical Trial Registry (ChiCTR2500095742).