Abstract
BACKGROUND: Monitored anesthesia care (MAC) is increasingly utilized in diagnostic hysteroscopy to ensure patient comfort while maintaining safety. Among various agents, remifentanil and midazolam are commonly employed, but comparative data on their sedation quality and maternal-fetal safety profiles during hysteroscopy in reproductive-age women remain limited. METHODS: This prospective, randomized, controlled trial included 120 women undergoing diagnostic hysteroscopy. Participants were randomized into two groups: Group R (remifentanil infusion at 0.05-0.1 µg/kg/min) and Group M (midazolam bolus 0.05 mg/kg followed by 0.02 mg/kg as needed). Primary outcomes were sedation quality (Ramsay Sedation Score [RSS], patient and surgeon satisfaction), and secondary outcomes included hemodynamic stability, recovery time, and fetal safety indicators (serum β-hCG and uterine perfusion on Doppler ultrasonography pre- and post-procedure). RESULTS: Group R had significantly better sedation depth (RSS: 3.8 ± 0.6 vs. 2.9 ± 0.5, P < 0.001), shorter recovery time (11.2 ± 2.1 min vs. 24.7 ± 3.6 min, P < 0.001), and higher patient satisfaction (94.1% vs. 78.3%, P = 0.018). Hemodynamic parameters remained stable in both groups. No significant difference was found in fetal safety markers (serum β-hCG: P = 0.41; uterine perfusion index: P = 0.57). CONCLUSION: Remifentanil provides superior sedation quality and faster recovery without compromising maternal-fetal safety compared to midazolam during MAC for diagnostic hysteroscopy. It is a viable alternative for short gynecological procedures in reproductive-age women.