Efficacy and safety of ciprofol for sedation/anesthesia in patients undergoing hysteroscopy: a prospective, randomized, non-inferiority trial.

INTRODUCTION

Propofol is the preferred sedative for painless hysteroscopy and other procedures due to its fast onset and short duration. However, its limitations, including injection pain, respiratory depression, blood pressure decline, and bradycardia, cannot be disregarded. Ciprofol, a new short-acting gamma-aminobutyric acid receptor agonist, has shown effectiveness and safety in painless gastrointestinal endoscopy. This study aims to demonstrate that ciprofol is not inferior to propofol in terms of sedation efficacy for painless hysteroscopy.

PATIENTS AND METHODS

A randomized study was conducted with 124 women to evaluate the anesthetic effect of ciprofol during outpatient painless hysteroscopy. The primary outcome assessed was the success rate of hysteroscopy, while secondary indicators included induction and recovery time, injection pain, tidal volume and respiratory rate. Safety indicators comprised hypotension, hypoxemia, and sinus bradycardia.

RESULTS

A total of 124 patients were enrolled in the study, with 62 in each group. The success rate of hysteroscopy was 100% in both groups. Patients in the ciprofol group had higher diastolic pressure, pulse oxygen saturation levels and minute breathing during surgery than patients in the propofol group, but their induction time and recovery time were longer. The proportion of patients in the propofol group who reported pain during intravenous anesthesia was 41.935%, which was significantly higher than that of patients in the ciprofol group (1.613%).

CONCLUSION

During painless hysteroscopy, ciprofol demonstrates non-inferiority to propofol in terms of anesthetic efficacy. Despite slightly longer induction and recovery times, ciprofol results in lower instances of injection pain and less impact on respiration and circulation compared to propofol.

TRIAL NUMBER

Clinical trial Registration Identifier: NCT06172140.