Efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil during fiberoptic bronchoscopy: A prospective, randomized, double-blind, non-inferiority trial

Abstract

Objective: Ciprofol is a novel 2,6-disubstituted phenol derivative that has improved pharmacokinetic and pharmacodynamic properties compared with propofol. This study was conducted to compare the efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil for patients undergoing fiberoptic bronchoscopy.Methods: Overall, 92 patients undergoing fiberoptic bronchoscopy were included in this prospective, randomized, double-blind, non-inferiority trial and were equally divided into two groups (n = 46 each). Fentanyl (50 μg) was given 2 min before the intravenous infusion of 0.3 mg/kg of ciprofol or 1.2 mg/kg of propofol over a time period of 30 s. During anesthesia maintenance, 0.05–0.2 μg/kg/min of remifentanil combined with one-third to one-fourth of the initial dose of ciprofol or propofol was repeated at 2-min intervals, as required, to maintain a Modified Observer’s Assessment of Alertness and Sedation (MOAA/S) scale score <3. The primary outcome was the successful rate of fiberoptic bronchoscopy. Secondary outcomes included demographic characteristics, time metrics, hemodynamics, coughing severity, intubating conditions, lowest oxygen saturation, utilization of study drug doses, number of remedies (lidocaine and vasoactive drugs) used, satisfaction scores of both patients and the endoscopist, occurrence of intraoperative awareness, patients’ willing to repeat fiberoptic bronchoscopy, and occurrence and severity of adverse events.Results: The successful completion rate of fiberoptic bronchoscopy was 91.30% (42 of 46; 95% confidence interval [CI]: 82.80%–99.80%) in the ciprofol-remifentanil group and 89.13% (41 of 46; 95% CI: 79.80%–98.50%) in the propofol-remifentanil group. Though the clinically acceptable intubating condition was improved in the ciprofol-remifentanil group, this difference has no clinical statistical difference (p > 0.05). No significant differences were noted between the two groups with respect to time metrics, consumption of fentanyl and remifentanil, or number of remedies (lidocaine and vasoactive drugs). Patients’ willingness to repeat fiberoptic bronchoscopy and the satisfaction of both patients and endoscopist were significantly higher in the ciprofol-remifentanil than in the propofol-remifentanil group (p < 0.05). Compared with patients in the propofol-remifentanil group, patients in the ciprofol-remifentanil group had more stable hemodynamics. The lowest oxygen saturation was significantly higher in the ciprofol-remifentanil than in the propofol-remifentanil group (p < 0.05). The numbers of patients who experienced pain on injection in the ciprofol-remifentanil group was significantly lower than the number in the propofol-remifentanil group (p < 0.01). Severity of coughing, clinically acceptable severity of coughing, incidence of intraoperative awareness, and other adverse events were all similar between the two groups (p > 0.05). Only four patients experienced grade 2 adverse events (severe hypotension in one patient in the ciprofol-remifentanil group and three patients in the propofol-remifentanil group; p > 0.05); they were treated with noradrenaline.Conclusion: Ciprofol-remifentanil was non-inferior to propofol-remifentanil with regard to successful sedation for flexible bronchoscopy, when used with pre-intravenous administration of 50 μg of fentanyl. At the same time, patients’ willingness to repeat flexible bronchoscopy and the satisfactions were all significantly improved.

Comparative effective dose of ciprofol and propofol in suppressing cardiovascular responses to tracheal intubation: a single-center, double-blind, randomized, controlled clinical trial

“…This aligns with effective doses reported in earlier phase I-III studies and provides a more precise estimation. Our study reveals a slightly higher effective dose of ciprofol compared to the 0.3 mg/kg recommended by Wu 15 , Ding 16 , and Duan 17 . This variation may be due to the different stimulation intensities between beroptic bronchoscopy and tracheal intubation, and the use of topical anesthesia in Wu's study prior to bronchoscope insertion.…”

ED50 of Ciprofol Combined with Sufentanil for Fiber Bronchoscopy of Different Patient Populations with Pulmonary Tuberculosis

“…Patients undergoing beroptic bronchoscopy should use sedatives to improve comfort, alleviate anxiety, and reduce surgical complications [9]. Ciprofol is a short-acting intravenous sedative based on the structural modi cation of propofol, whose main mechanism is to activate the postsynaptic GABA-A-Clchannel complex, which causes hyperpolarization of nerve cell membrane through chloride ion in ux, thus causing central nervous system inhibition [15][16][17].…”

“…Ciprofol, a 2,6-phenol derivative, has the advantages of rapid onset, high therapeutic index, low incidence of respiratory and cardiac function inhibition, and reduced injection pain, which is a promising sedative [5][6][7]. The effectiveness and safety of ciprofol for beroptic bronchoscopy are rarely studied [8,9], and there is no report on the median effective dose (ED50) of ciprofol for special populations such as TB patients. A previous pharmacokinetic study of ciprofol in healthy Chinese population found that the ED of ciprofol in the non-elderly was different from the elderly [10].…”

A systematic review and meta-analysis comparing the efficacy and safety of ciprofol (HSK3486) versus propofol for anesthetic induction and non-ICU sedation

“…The ASA physical status classification varied from I to IV with ASA II being the most common. Nine studies included patients with ASA I-II (Teng et al, 2021;Chen et al, 2022a;Chen et al, 2022b;Li et al, 2022;Wang et al, 2022;Wu et al, 2022;Liang et al, 2023;…”