The efficacy and safety of ciprofol versus propofol in patients undergoing painless hysteroscopy: a randomized, double-blind, controlled trial

Background Studies have reported that ciprofol has the advantage of reducing injection pain compared to propofol during gastroscopy, colonoscopy, and fiberoptic bronchoscopy. The effect of ciprofol on the injection pain in painless hysteroscopy needs to further explore. Methods A double-blind randomized controlled trial (RCT) was designed, and patients were recruited from the First Central Hospital of Baoding from March 2024 to June 2024. The eligible participants were allocated into ciprofol group (ciprofol combined with alfentanil) and propofol group (propofol combined with alfentanil) at 1:1 ratio. The primary outcome was injection pain. The secondary outcomes included sedation success rate, anesthesia success rate, adverse events, patient satisfaction, and comparison of vital signs before and after administration. Results A total of 217 participants were included for analysis, with 109 participants in the ciprofol group and 108 participants in the propofol group. The injection pain rate of ciprofol group (18.35%) was significantly lower than the propofol group (40.74%). Both the ciprofol group and propofol group had 100% of the sedation success rate. The anesthesia success rate between the two groups was comparable (P > 0.05). The rate of adverse events was lower (27.52% vs. 45.37%) and patient satisfaction was higher (9.84 +/- 0.45 vs. 9.65 +/- 0.85) in the ciprofol group than the propofol group. In addition, values of systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) in propofol group were significantly lower than those in ciprofol group at the time of cervical dilation and consciousness recovery. Conclusions Ciprofol exhibits comparable efficacy to that of propofol, and is associated with less injection pain rate, fewer adverse events, higher patient satisfaction, and more stable hemodynamics when used for general anesthesia during the painless hysteroscopy. Clinical trial number NCT06413862.