Ciprofol-etomidate versus propofol-etomidate for gastrointestinal endoscopy: a randomized, double-blind controlled clinical trial

OBJECTIVE: Explore the clinical efficacy and safety of ciprofol‐etomidate (C‐E) versus propofol‐etomidate (P‐E) for gastrointestinal endoscopy sedation, and generate hypotheses for subsequent prospective pre‐registered trials. METHODS: A prospective, double‐blind, randomized, positive‐controlled exploratory trial enrolled 240 adults (120 per group). Exploratory outcomes included hemodynamics, adverse events, and Chalder Fatigue Questionnaire (CFQ) scores. Intention‐to‐treat (ITT) analysis was primary, with per‐protocol analysis (PPA, n = 223) as sensitivity validation. RESULTS: C‐E group showed significantly lower CFQ Bimodal scores ≥4, postoperative dizziness incidence, and blood pressure fluctuations (>20% baseline; all p < 0.05). One P‐E patient needed respiratory support for SpO₂ = 85%. Other outcomes (e.g., induction time, total dose) were comparable. ITT and PPA results were consistent. CONCLUSION: This retrospective registered exploratory study tentatively suggests C‐E may offer potential advantages in hemodynamic stability, respiratory safety, and reduced post‐procedural fatigue/dizziness for low‐risk (ASA I   II) patients. Findings are hypothesis‐generating and require validation via prospective pre‐registered trials. SYSTEMATIC REVIEW REGISTRATION: https://www.chictr.org.cn/indexEN.html, identifier ChiCTR2500107221.