Abstract / Summary
Ultrasound-guided percutaneous radiofrequency ablation (PRFA) is an effective treatment for small hepatocellular carcinoma, but anesthesia management in patients with liver cancer and comorbidities remains challenging. This study aimed to compare the anesthetic efficacy and safety of remimazolam combined with remifentanil versus propofol in patients undergoing PRFA. Eighty-two participants were randomly assigned to receive either propofol (Group P, n = 41) or remimazolam (Group R, n = 41) for anesthesia, both combined with remifentanil for analgesia. The primary outcome was mean arterial pressure (MAP) across seven perioperative time points. Secondary outcomes included heart rate (HR), Cerebral State Index (CSI), oxygen saturation (SpO2), respiratory parameters, recovery time, and adverse events. Primary analysis followed the intention-to-treat (ITT) principle using linear mixed-effects models. A per-protocol sensitivity analysis was also performed. In the ITT analysis (n = 82), linear mixed-effects models showed a significant group × time interaction for MAP (F[6, 77.139] = 11.913, p < 0.001), with higher MAP in Group R at T2, T4, and T5. Significant interactions were also observed for CSI and HR, but not for SpO2. Group R had higher respiratory rate (p = 0.015), lower apnea incidence (17.1% vs 36.6%, p = 0.038), lower PETCO2 (p < 0.001), less hypotension requiring vasopressors (22.0% vs 46.3%, p = 0.015), and longer time to achieve an MOAA/S score ≤1 (19.61 ± 2.68 vs 15.20 ± 1.58 s, p< 0.001). Recovery time was shorter in Group R (9.65 ± 1.81 vs 15.05 ± 3.58 min, p < 0.001), noting flumazenil was given only to Group R. No differences were found in pain scores or liver function tests. Remimazolam with remifentanil provided better hemodynamic stability and respiratory safety than propofol in PRFA for liver cancer (Child-Pugh A/B, without severe comorbidities). The shorter recovery time, though partly confounded by flumazenil, supports remimazolam as a promising alternative. Further studies in higher-risk patients are needed. The trial was registered before patient enrolment at http://www.chictr.org.cn (ChiCTR2300078192), and was registered on November 30, 2023.