ArticleFrontiers in medicine2024
Efficacy and safety of ciprofol for sedation in outpatient gynecological procedures: a phase III multicenter randomized trial.
Article in Frontiers in medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04958746 (A Multi-Center, Randomized, Double-Blind, Propofol Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries), which is not on this map. Cited by 4 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multi-Center, Randomized, Double-Blind, Propofol Parallel-Controlled Phase III Clinical Trial Evaluating the Efficacy and Safety of Ciprofol Injection for the Induction of Sedation/Anesthesia in Subjects Undergoing Gynecological Outpatient Surgeries
Who cites it
4 citing papers in PubMed, 1 synthesis or guideline pooled it.
- An updated evidence-informed framework for dental sedation: drugs, routes, patient selection, monitoring, and emergency preparedness.Frontiers in oral health · 2026Pooled it
- Ciprofol provides safer sedation than propofol in minor gynecologic surgery: evidence from a randomized controlled trial.Revista da Associacao Medica Brasileira (1992) · 2026Trial
- Intravenous Anesthesia with Ciprofol and Remimazolam Besylate for Painless Gastroscopy: A Prospective, Single-Center, Randomized Controlled Trial.Drug design, development and therapy · 2025Trial
- Review
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Objective: Ciprofol (also known as cipepofol and HSK3486), is a compound similar to propofol in chemical structure and hypnotic effect. Herein we evaluated the efficacy and safety of ciprofol for sedation in outpatient gynecological procedures. Methods: This phase III multicenter randomized trial with a non-inferiority design was conducted in nine tertiary hospitals. We enrolled 135 women aged 18-65 years who were scheduled for ambulatory gynecological procedures. Patients were randomly assigned to receive either ciprofol (0.4 mg/kg for induction and 0.2 mg/kg for maintenance) or propofol (2.0 mg/kg for induction and 1.0 mg/kg for maintenance) sedation in a 2:1 ratio. Patients and investigators for data collection and outcome assessment were blinded to study group assignments. The primary outcome was the success rate of sedation, defined as completion of procedure without remedial anesthetics. The non-inferiority margin was set at -8%. Secondary outcomes included time to successful induction, time to full awake, time to meet discharge criteria, and satisfaction with sedation assessed by patients and doctors. We also monitored occurrence of adverse events and injection pain. Results: A total of 135 patients were enrolled; 134 patients (90 patients received ciprofol sedation and 44 patients propofol sedation) were included in final intention-to-treat analysis. The success rates were both 100% in the two groups (rate difference, 0.0%; 95% CI, -4.1 to 8.0%), i.e., ciprofol was non-inferior to propofol. When compared with propofol sedation, patients given ciprofol required more time to reach successful induction (median difference [MD], 2 s; 95% CI, 1 to 7; Conclusion: Ciprofol for sedation in ambulatory gynecological procedures was non-inferior to propofol, with less adverse events and injection pain. Clinical trial registration: ClinicalTrials.gov, identifier NCT04958746.
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