Drug design, development and therapy · 2026
Comparison of Incidence of Respiratory Depression Between Ciprofol versus Propofol for Procedural Sedation During First-Trimester Surgical Abortion: A Randomized Controlled Trial.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Chen Jing, Zhang Ting, Zhang Conghui, Xia Lingyi, Zeng Linghua, Zhu Yunyan, Zhu Junjie, Wang Yi, Hua Fuzhou, Liang Weidong
Аннотация
BACKGROUND: Respiratory depression remains a major safety concern during propofol-based sedation for surgical abortion. Ciprofol is a novel intravenous sedative-hypnotic agent with pharmacological properties similar to propofol and a potentially improved safety profile. This randomized controlled trial aimed to compare the incidence of respiratory depression of ciprofol versus propofol, both combined with alfentanil, for procedural sedation in patients undergoing surgical abortion.
METHODS: In this single-center, assessor-blinded, randomized controlled trial, 234 patients scheduled for surgical abortion under intravenous anesthesia were assessed for eligibility, and 226 were randomly assigned to receive either ciprofol (0.4 mg/kg; n=113) or propofol (2.0 mg/kg; n=113). Alfentanil (7.5 μg/kg) was administered intravenously as part of anesthesia induction in all patients. The primary outcome was the incidence of respiratory depression (SpO2 <90% requiring airway intervention) throughout the anesthesia and surgical procedure. Secondary outcomes included the overall incidence of perioperative adverse events as a composite safety endpoint defined as the occurrence of at least one prespecified adverse event from induction to discharge. Additional anesthesia-related variables, including induction characteristics, hemodynamic changes, depth of sedation, post-procedure pain scores, and patient satisfaction, were evaluated as exploratory outcomes.
RESULTS: Under the same anesthesia depth, respiratory depression occurred less frequently with ciprofol than with propofol (9.7% vs 20.4%, P=0.026). The overall incidence of perioperative adverse events was lower in the ciprofol group (28.3% vs 64.6%, P < 0.001). Injection pain was observed in 34.5% of patients receiving propofol and in none receiving ciprofol. PONV, hemodynamic instability, procedure time, time to discharge, post-procedure pain scores and patient satisfaction were comparable between groups. No serious adverse events occurred.
CONCLUSION: Ciprofol combined with alfentanil was associated with a lower incidence of respiratory depression and perioperative adverse events than propofol, while providing comparable procedural sedation efficacy in patients undergoing surgical abortion.
METHODS: In this single-center, assessor-blinded, randomized controlled trial, 234 patients scheduled for surgical abortion under intravenous anesthesia were assessed for eligibility, and 226 were randomly assigned to receive either ciprofol (0.4 mg/kg; n=113) or propofol (2.0 mg/kg; n=113). Alfentanil (7.5 μg/kg) was administered intravenously as part of anesthesia induction in all patients. The primary outcome was the incidence of respiratory depression (SpO2 <90% requiring airway intervention) throughout the anesthesia and surgical procedure. Secondary outcomes included the overall incidence of perioperative adverse events as a composite safety endpoint defined as the occurrence of at least one prespecified adverse event from induction to discharge. Additional anesthesia-related variables, including induction characteristics, hemodynamic changes, depth of sedation, post-procedure pain scores, and patient satisfaction, were evaluated as exploratory outcomes.
RESULTS: Under the same anesthesia depth, respiratory depression occurred less frequently with ciprofol than with propofol (9.7% vs 20.4%, P=0.026). The overall incidence of perioperative adverse events was lower in the ciprofol group (28.3% vs 64.6%, P < 0.001). Injection pain was observed in 34.5% of patients receiving propofol and in none receiving ciprofol. PONV, hemodynamic instability, procedure time, time to discharge, post-procedure pain scores and patient satisfaction were comparable between groups. No serious adverse events occurred.
CONCLUSION: Ciprofol combined with alfentanil was associated with a lower incidence of respiratory depression and perioperative adverse events than propofol, while providing comparable procedural sedation efficacy in patients undergoing surgical abortion.