Efficacy and safety of ciprofol for sedation/anesthesia in patients undergoing hysteroscopy: a randomized, single-blind, parallel-group, controlled trial

Abstract

Abstract Objective: To compare the efficacy and safety of ciprofol and propofol for hysteroscopy. Methods: A total of 150 patients undergoing hysteroscopy were randomly assigned to a ciprofol (Group C) or propofol group (Group P). Group C received an induction dose of 0.4 mg/kg and a maintenance dosage of 1.0 mg/kg/h. In Group P, propofol was started at 2.0 mg/kg and then maintained at 5.0 mg/kg/h. All cases received intravenous sufentanil 0.1 µg/kg for analgesic preconditioning. Changes in heart rate, systolic and diastolic blood pressure, mean arterial pressure, peripheral oxygen saturation, and bispectral index were recorded after admission (T0), before the initiation of sedative infusion (T1), 2 min after anesthesia (T2), 5 min after anesthesia (T3), 10 min after anesthesia (T4), end of operation (T5), 5 min after operation (T6), and 10 min after operation (T7). Additionally, the incidence rates of adverse events, disappearance time of the eyelash reflex, and the awakening time were compared between the two groups. Results: The success rate of sedation in each group was 100%. The mean eyelash reflex disappearance and awakening times were 1.4 min and 5.4 min, respectively, for ciprofol and 1.2 min and 4.6 min, respectively, for propofol. The bispectral index change pattern for ciprofol was similar to that of propofol and was stable during maintenance of anesthesia. After drug administration, the blood pressure in Group C was more stable than that in Group P (P< 0.001). The incidence of respiratory adverse events in Group P (23.0%) was much higher than that in Group C (2.7%) (P< 0.001). The incidence of injection pain in Group C was significantly lower than that in Group P (P< 0.001). No serious adverse events occurred in any patients. Conclusions: Ciprofol proved to be a safer alternative than propofol for anesthesia during hysteroscopy. Compared with propofol, ciprofol does not cause injection pain, exerts less effect on hemodynamics, and causes less respiratory depression.