Drug design, development and therapy · 2025
Comparison of Ciprofol-Based and Propofol-Based Total Intravenous Anesthesia on Postoperative Recovery Quality in Patients Undergoing Hysteroscopic Surgery: A Randomized Non-Inferiority Trial.
Сравнительное исследованиеEquivalence TrialСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Yang Huan, Yang Yan, Huang Yihao, Liu Tao, Wang Yiheng
Аннотация
PURPOSE: The 2,6-disubstituted alkylphenol ciprofol is a novel propofol analog for induction and maintenance of anesthesia. We aimed to compare the effects of ciprofol-based and propofol-based total intravenous anesthesia (TIVA) on postoperative recovery quality following hysteroscopic surgery.
PATIENTS AND METHODS: In this randomized non-inferiority trial, women scheduled for hysteroscopic surgery at a tertiary hospital were randomly assigned to the ciprofol or propofol groups. The patients were administered intravenous injections of ciprofol (0.4 mg/kg) or propofol (2.0 mg/kg) for anesthesia induction before a maintenance infusion at initial rates of 0.8 or 5.0 mg/kg/h, respectively. The primary outcome was the Quality of Recovery-15 scale (QoR-15) score at 24 h post-surgery, and a non-inferiority margin of -8 was assumed. The secondary outcomes included hemodynamic changes, time to consciousness loss and recovery, incidences of injection pain, body movement, intraoperative respiratory adverse events, and postoperative adverse events.
RESULTS: The trial included 120 participants (60 per group). The total QoR-15 score 24 h after surgery in the ciprofol group was comparable to that in the propofol group (median [interquartile range]: 113.5 [111.0, 117.0] vs 112.5 [108.0, 117.0]; median difference [95% confidence interval]: -1.0 [-3.0, 2.0]). There were no significant differences in the five QoR-15 dimensions between the groups. The mean arterial pressure and heart rate during anesthesia induction and surgery were significantly higher in the ciprofol group than in the propofol group, whereas the incidence of injection pain was lower. In addition, there were no significant between-group differences in the time to loss of consciousness or awakening, incidences of intraoperative hypoxemia or laryngospasm, or incidences of postoperative nausea, vomiting, headache, dizziness, and drowsiness.
CONCLUSION: Ciprofol is not inferior to propofol in terms of QoR score. Ciprofol administration is suitable for general anesthesia in female patients during hysteroscopic surgery.
PATIENTS AND METHODS: In this randomized non-inferiority trial, women scheduled for hysteroscopic surgery at a tertiary hospital were randomly assigned to the ciprofol or propofol groups. The patients were administered intravenous injections of ciprofol (0.4 mg/kg) or propofol (2.0 mg/kg) for anesthesia induction before a maintenance infusion at initial rates of 0.8 or 5.0 mg/kg/h, respectively. The primary outcome was the Quality of Recovery-15 scale (QoR-15) score at 24 h post-surgery, and a non-inferiority margin of -8 was assumed. The secondary outcomes included hemodynamic changes, time to consciousness loss and recovery, incidences of injection pain, body movement, intraoperative respiratory adverse events, and postoperative adverse events.
RESULTS: The trial included 120 participants (60 per group). The total QoR-15 score 24 h after surgery in the ciprofol group was comparable to that in the propofol group (median [interquartile range]: 113.5 [111.0, 117.0] vs 112.5 [108.0, 117.0]; median difference [95% confidence interval]: -1.0 [-3.0, 2.0]). There were no significant differences in the five QoR-15 dimensions between the groups. The mean arterial pressure and heart rate during anesthesia induction and surgery were significantly higher in the ciprofol group than in the propofol group, whereas the incidence of injection pain was lower. In addition, there were no significant between-group differences in the time to loss of consciousness or awakening, incidences of intraoperative hypoxemia or laryngospasm, or incidences of postoperative nausea, vomiting, headache, dizziness, and drowsiness.
CONCLUSION: Ciprofol is not inferior to propofol in terms of QoR score. Ciprofol administration is suitable for general anesthesia in female patients during hysteroscopic surgery.