Drug design, development and therapy · 2025
Intravenous Anesthesia with Ciprofol and Remimazolam Besylate for Painless Gastroscopy: A Prospective, Single-Center, Randomized Controlled Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Li Lin, Zhu Yusi, Zhu Jie, Zeng Mingyue, Duan Yu, Cheng Pengfei, Zhou Xiang
Аннотация
PURPOSE: To evaluate whether combining ciprofol and remimazolam offers superior safety and efficacy compared to propofol or ciprofol monotherapy for sedation during painless gastroscopy. We hypothesize improved hemodynamic and respiratory stability with the combination.
METHODS: A total of 641 patients undergoing gastroscopy were randomly assigned to one of three groups. Group P (Propofol) received an intravenous bolus of propofol at a dose of 1.5 mg/kg. Group CR (Ciprofol + Remimazolam) received an initial intravenous dose of remimazolam (0.08 mg/kg), followed by ciprofol (0.25 mg/kg). Group C (Ciprofol) received an intravenous bolus of ciprofol at a dose of 0.4 mg/kg. Sedation depth was maintained within the target range (Bispectral Index 40-60) through the administration of supplemental doses: propofol (10-20 mg boluses) in Group P, and ciprofol (2.5-5 mg boluses) in Groups CR and C.
RESULTS: Compared with group P, groups CR and C demonstrated significantly lower incidences of hypotension (CR: 7.8% vs P: 21.6%; C: 12.3% vs P: 21.6%; all P values < 0.001), mild hypoxia (CR: 8.8% vs P: 18.1%, P = 0.005; C: 7.7% vs P: 18.1%, P=0.001), and severe hypoxia (CR: 4.6% vs P: 9.8%, P = 0.038; C: 4.1% vs P: 9.8%, P = 0.020). Group C exhibited significantly longer induction time (1.62 ± 0.66 min, P < 0.001), recovery time (13.73 ± 3.82 min, P < 0.001), and operating room time (23.05 ± 6.38 min, P < 0.001) compared to both other groups. Additionally, gastroenterologist and anesthesiologist satisfaction was significantly higher in group CR than in groups P and C (all P values < 0.001).
CONCLUSION: The combination of ciprofol and remimazolam exerts a lesser impact on the respiration and circulation of patients undergoing gastroscopy, and demonstrates superior safety and efficacy compared to the use of propofol or ciprofol alone.
METHODS: A total of 641 patients undergoing gastroscopy were randomly assigned to one of three groups. Group P (Propofol) received an intravenous bolus of propofol at a dose of 1.5 mg/kg. Group CR (Ciprofol + Remimazolam) received an initial intravenous dose of remimazolam (0.08 mg/kg), followed by ciprofol (0.25 mg/kg). Group C (Ciprofol) received an intravenous bolus of ciprofol at a dose of 0.4 mg/kg. Sedation depth was maintained within the target range (Bispectral Index 40-60) through the administration of supplemental doses: propofol (10-20 mg boluses) in Group P, and ciprofol (2.5-5 mg boluses) in Groups CR and C.
RESULTS: Compared with group P, groups CR and C demonstrated significantly lower incidences of hypotension (CR: 7.8% vs P: 21.6%; C: 12.3% vs P: 21.6%; all P values < 0.001), mild hypoxia (CR: 8.8% vs P: 18.1%, P = 0.005; C: 7.7% vs P: 18.1%, P=0.001), and severe hypoxia (CR: 4.6% vs P: 9.8%, P = 0.038; C: 4.1% vs P: 9.8%, P = 0.020). Group C exhibited significantly longer induction time (1.62 ± 0.66 min, P < 0.001), recovery time (13.73 ± 3.82 min, P < 0.001), and operating room time (23.05 ± 6.38 min, P < 0.001) compared to both other groups. Additionally, gastroenterologist and anesthesiologist satisfaction was significantly higher in group CR than in groups P and C (all P values < 0.001).
CONCLUSION: The combination of ciprofol and remimazolam exerts a lesser impact on the respiration and circulation of patients undergoing gastroscopy, and demonstrates superior safety and efficacy compared to the use of propofol or ciprofol alone.