Comparison of Ciprofol Versus Propofol for the General Anaesthesia During Gynecological Day Surgery: A Prospective, Randomized, Double-Blind, Non-Inferiority Trial.

PURPOSE

To compare the safety and efficacy of ciprofol and propofol in general anesthesia for gynecological day surgery.

PATIENTS AND METHODS

A total of 196 patients undergoing gynecological day surgery under general anesthesia were randomly divided into ciprofol and propofol group. All patients received total intravenous anesthesia. Anesthesia induction in the ciprofol group: ciprofol 0.5 mg/kg was given intravenously within 1 minute, alfentanil 20 μg/kg was given intravenously within 30 seconds, mivacurium 0.2 mg/kg was given intravenously within 30 seconds, and anesthesia maintenance: ciprofol 1.25 mg/kg/h combined with alfentanil 40 μg/kg/h was given intravenously. Anesthesia induction in the propofol group, propofol 2 mg/kg was administered intravenously within 1 min, alfentanil 20μg/kg was given intravenously within 30s, mivacurium 0.2 mg/kg was administered intravenously within 30s, and anesthesia maintenance: propofol 5 mg/kg/h combined with alfentanil 40 μg/kg/h was administered intravenously. The primary outcome was the success rate of anesthesia (defined as the number of additional study drugs administered ≤ 2 times during anesthesia induction and ≤ 2 times within 10 min during anesthesia maintenance). The secondary outcomes included time to loss of consciousness, hemodynamic changes, depth of anesthesia at different time points, additional narcotic drugs during anesthesia, use of vasoactive agents, awakening time, and incidence of adverse reactions.

RESULTS

The success rate of anesthesia in both groups was 100%. There was no difference in the time of consciousness disappearance between the two groups during induction (81.95 vs 79.54s). Compared with the propofol group, the hemodynamics in the ciprofol group were more stable, the depth of anesthesia was better, the number of additional medications was significantly reduced, and the incidence of postoperative adverse reactions was significantly reduced. However, the awakening time of the ciprofol group was significantly longer than that of the propofol group (7.57 vs 5.52 min).

CONCLUSION

Ciprofol demonstrated non-inferior efficacy to propofol for gynecological day surgery anesthesia, while offering superior hemodynamic stability and reduced adverse effects.