Enhanced hemodynamic stability and patient satisfaction with ciprofol-remifentanil versus propofol-remifentanil for sedation in shorter-duration fiberoptic bronchoscopy: a prospective, randomized, double-blind study

Abstract

Objective: This study aimed to compare the efficacy and safety of ciprofol-remifentanil versus propofol-remifentanil in patients undergoing fiberoptic bronchoscopy (FOB).

Methods: In this prospective, randomized, double-blind, non-inferiority trial, 209 patients undergoing FOB were enrolled and equally divided into two groups (n = 106 each). The trial was registered in the Chinese Clinical Trial Registry (ChiCTR) under the registration number ChiCTR2400081603. Patients in the ciprofol-remifentanil group received ciprofol at a dose of 0.4 mg/kg, while those in the propofol-remifentanil group received propofol at a dose of 2.5 mg/kg. Both groups were pre-medicated with 1 μg/kg of remifentanil. Anesthesia was maintained with additional doses of the respective anesthetic agent as required to achieve a Modified Observer's Assessment of Alertness and Sedation (MOAA/S) scale score of ≤1. The primary outcome was the successful completion rate of FOB. Secondary outcomes included hemodynamic stability, incidence of adverse events such as hypoxemia and hypotension, patient and physician satisfaction, and the incidence of pain on injection.

Results: The successful completion rate of FOB was 92.45% (98 of 106) in the ciprofol-remifentanil group and 90.57% (96 of 106) in the propofol-remifentanil group (p > 0.05). The ciprofol-remifentanil group demonstrated more stable hemodynamics, with significantly lower incidences of hypotension and hypoxemia compared to the propofol-remifentanil group (p < 0.05). Patient and physician satisfaction scores were significantly higher in the ciprofol-remifentanil group (p < 0.05). Additionally, the incidence of pain on injection was significantly lower in the ciprofol-remifentanil group (p < 0.01). Other adverse events, including coughing severity and intraoperative awareness, were similar between the two groups (p > 0.05).

Conclusion: Ciprofol-remifentanil was non-inferior to propofol-remifentanil in terms of sedation during fiberoptic bronchoscopy;. Furthermore, ciprofol-remifentanil was associated with greater hemodynamic stability, reduced pain on injection, and higher satisfaction scores, suggesting that it may be a preferable alternative to propofol-remifentanil for FOB procedures.

Clinical trial registration: https://www.chictr.org.cn/, ChiCTR2400081603.

Keywords: ciprofol; fiberoptic bronchoscopy; hemodynamic; propofol; sedation.

Figure 1

Patient flowchart with CONSORT guidelines.

Figure 2

Hemodynamic and respiratory changes during FOB under Ciprofol-remifentanil (C group) and Propofol-remifentanil (P group). (A) Oxygen saturation (SpO₂) over time, showing significantly higher SpO₂ levels in the C group compared to the P group at T2 (after nasopharyngeal tube insertion), T3 (after bronchoscope enters the carina), and T5 (at the end of the examination). (B) Heart rate (HR) remained relatively stable across all time points, with no significant differences between the C and P groups. (C) Mean arterial pressure (MAP) showed better stability in the C group, with significantly higher values at T1 (after drug administration), T3, and T4 compared to the P group. (D) Respiratory rate (RR) was significantly higher in the C group at T1, T3, and T4, indicating more stable respiratory function in the C group. p values indicate significant differences between the C and P groups at specific time points. Error bars represent standard deviations.

Figure 3

Secondary outcomes and safety parameters in Ciprofol-remifentanil (C group) and Propofol-remifentanil (P group) groups during FOB. (A) Time metrics including total examination duration, recovery of consciousness time, and recovery room stay time. Recovery of consciousness was significantly faster in the P group compared to the C group (p < 0.001). (B) Number of patients with SpO₂ < 95%, use of ephedrine, and hypotension management. The P group had significantly more patients requiring intervention for hypotension (p < 0.0001). (C) Incidence of adverse events, including dizziness, injection pain, and choking cough after medication administration. The P group experienced more adverse events compared to the C group, with significant differences in injection pain (p < 0.0001) and choking cough (p = 0.007). (D) Satisfaction scores for physicians and patients. Physician satisfaction was significantly higher in the C group compared to the P group (p = 0.012). (E) Sedation depth measured by the Clinical Respiratory Score (CRS) and the Modified Observer’s Assessment of Alertness/Sedation (MOAA/S). No significant differences were observed between the groups. (F) Time of loss of consciousness was significantly longer in the C group compared to the P group (p < 0.001). Error bars represent standard deviations.