Respiratory-related safety profiles of ciprofol (cipepofol) for anesthesia/sedation in Chinese elderly patients undergoing gastroscopy: a multicenter, parallel controlled clinical trial (REST trial)
Authors' conclusion
Cipepofol-0.3 mg/kg is a safe and effective intravenous anesthetic for Chinese elderly patients undergoing gastroscopy, especially complimented by lower incidences of respiratory-related AEs and injection pain.
Study context
- Population
- Chinese elderly patients aged ≥65 years undergoing gastroscopy871 in full analysis set
- Participants
- 890 patients
- Comparison
- Cipepofol vs Propofol
- Cipepofoln = 431
- Propofoln = 440reference
- Primary endpoint
- Incidence of respiratory-related AEs: respiratory depression (respiratory rate < 8 breaths/min >30 s), apnea (loss of thoracic movement >15 s), hypoxemia (SpO2 < 93 % >15 s)
Methodological detailspost-marketing, parallel-controlled, multicentre
- Post-marketing
- Parallel-controlled
- Multicentre
Primary result
As reported in the abstract
Respiratory-related AEs (full analysis set (FAS))
P < 0.001
Secondary outcomes
Respiratory-related AEs (per-protocol set) · per-protocol set
P < 0.001
Success rates of gastroscopy procedure and gastroscope insertion
Respiratory-related adverse events (AEs), multivariable analysis
- Risk 1.82 times higher with propofol vs cipepofol (P < 0.001)
Gastroscopy procedure-related durations
- Shorter with propofol vs cipepofol (all P < 0.05)
Safety
Treatment-emergent AEs (TEAEs)
P < 0.001
TEAEs of special interest
P < 0.001
Injection pain
P < 0.001
Original publication
Respiratory-related safety profiles of ciprofol (cipepofol) for anesthesia/sedation in Chinese elderly patients undergoing gastroscopy: a multicenter, parallel controlled clinical trial (REST trial). J Clin Anesth. Published 23 August 2025. doi:10. 1016/ j. jclinane. 2025. 111976
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