Efficacy and safety of ciprofol compared to propofol during hysteroscopy: a single-centre, randomized, positive-controlled study

Background: Sedation is frequently performed to alleviate the discomfort associated with hysteroscopy. Ciprofol, an isomer of propofol, exhibits rapid onset and recovery characteristics and may serve as an alternative sedative agent. This single-centre, randomized, positive-controlled study aimed to compare the efficacy and safety of ciprofol and propofol during hysteroscopy. Methods: A total of 94 women undergoing hysteroscopy were randomly allocated to receive either ciprofol or propofol. The primary endpoint was the sedation success rate, and the secondary endpoints included the time to effective sedation onset, time to full alertness, time to exit the operating room, cumulative sedative dose, incidence of injection pain, satisfaction levels, and occurrence of respiratory and circulatory adverse events (RAEs and CAEs). Results: Both groups achieved a 100% anesthesia success rate with no differences observed in time to effective sedation onset (40.0 ± 12.3 s vs. 44.9 ± 12.1 s, p = 0.056), time to full alertness (3.8 ± 1.8 min vs. 4.6 ± 2.9 min, p = 0.096), or time to exit the operating room (8.5 ± 2.6 min vs. 9.5 ± 4.6 min, p = 0.2) in the ciprofol versus propofol groups. The cumulative dose of ciprofol was 6 times lower than that of propofol (62.5 ± 26.7 mg vs. 380.6 ± 172.8 mg, p < 0.01). Compared with ciprofol, propofol resulted in a lower patient satisfaction rate (57.4% vs. 100%, p < 0.001) and a significantly higher incidence of injection pain (42.6% vs. 0.0%, p < 0.001). Additionally, RAEs and CAEs occurred more frequently in the propofol group than in the ciprofol group. Conclusions: Ciprofol provided sedation efficacy comparable to propofol during hysteroscopy, while demonstrating advantages in terms of lower anesthetic dosage, reduced incidence of injection pain, higher patient satisfaction, and fewer respiratory and circulatory adverse events. Clinical Trial Registration: This study was registered at http://www.chictr.org.cn (13 December 2022, ChiCTR2200066674).

Propofol; Ciprofol; Anesthesia; Sedation; Hysteroscopy

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