Ciprofol Versus Propofol for the Prevention of Hypoxia During Gastrointestinal Endoscopy Procedures in Overweight Patients: A Multicenter, Randomized, Controlled Trial.

BACKGROUND AND AIMS: To compare the incidence of hypoxia and other sedation-related adverse events (AEs) in overweight patients undergoing gastrointestinal (GI) endoscopy who were sedated using ciprofol or propofol.

METHODS

A randomized, controlled trial was conducted in five hospitals in China between September 2022 and August 2023. Patients were randomized into either ciprofol or propofol sedation. The primary outcome was the total incidence of hypoxia and severe hypoxia. The secondary outcomes were hypoxia incidence, severe hypoxia incidence, subclinical respiratory depression incidence, endoscopy success rate, injection pain incidence, and corrective hypoxic measures proportion.

RESULTS

A total of 1018 patients were randomized into either ciprofol group (n = 506) or propofol group (n = 512). The mean BMI was 26.23 kg/m2 in the ciprofol group and 26.17 kg/m2 in the propofol group. Compared with propofol, ciprofol showed lower incidences of total hypoxia and severe hypoxia in both the full analysis set (FAS) and per-protocol analysis set (PPS). The lower incidence was particularly significant for severe hypoxia (4.35% vs. 7.62%, p = 0.028 in FAS). The injection pain incidence was significantly lower in the ciprofol group than in the propofol group (2.57% vs. 13.28%, p < 0.001 in FAS). Moreover, fewer patients in the ciprofol group required oxygen-correction therapy (20.40% vs. 25.70%, p = 0.047 in PPS), and ciprofol had a lower incidence of AEs associated with sedation.

CONCLUSIONS

During GI endoscopy, overweight patients are significantly less prone to hypoxia when sedated with ciprofol than with propofol, offering a safer alternative.

TRIAL REGISTRATION: ClinicalTrials.gov (NCT05518929).