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.