[Comparative analysis of the efficacy of domestic and imported sugammadex for reversal of rocuronium-induced deep neuromuscular block in adult patients].

Abstract

Objective: To evaluate the efficacy of domestic and imported sugammadex for reversal of rocuronium-induced deep neuromuscular block (NMB) in adult patients. Methods: The clinical data of adult patients who scheduled for elective surgery with general anesthesia that required muscle relaxants in Peking University First Hospital from June 2023 to June 2024 were prospectively included. The patients were devided into domestic group and imported group according to random number table method. Anesthetized patients received rocuronium for intubation and muscle relaxation, and anesthesia was maintained with propofol, sevoflurane, and remifentanil. The effect of neuromuscular block was monitored. During deep muscle relaxation (with a single stimulation muscle twitch count of 1-2 after tetanic stimulation), domestic and imported sugammadex 4 mg/kg was given, respectively. The primary outcome was the recovery time from sugammadex injection to return of the train-of-four ratio (TOFr) to 0.9, with a non-inferiority margin of 1 minute (the range of non-inferiority boundary value is ±1 minute). The secondary outcome included the ratios of TOFr to 0.9 at different times and adverse effects. Results: A total of 70 patients were included, including 35 patients in the domestic group (13 males and 22 females), aged (46.9±12.7) years, and 35 patients in the imported group (13 males and 22 females), aged (45.7±11.5) years. There was no statistically significant difference in demographic characteristics, surgical time, anesthesia time, total rocuronium dose, and extubation time between two groups. All patients recovered to a TOFr of 0.9 within 5 minutes. Reversal time was 1.8 (1.3, 2.6) minutes in the domestic sugammadex group and 2.0 (1.7, 2.9) minutes in the imported sugammadex group respectively. The difference in reversal times between two groups was -0.40 minutes (95%CI:-0.75 to -0.02, P=0.039), which was within the range of non-inferiority threshold. Within 5 minutes of administration of antagonists, the incidence of bradycardia was 14% (5/35 and 5/35) in both domestic and imported groups. The incidence of skin allergy in patients transported to the post-anesthesia recovery room (PACU) was 3% (3/35) and 0 in both groups, respectively, with no statistical significance (all P>0.05). There were no serious drug-related adverse events in both groups. Conclusion: The effect of domestic sugammadex is not inferior to imported sugammadex in reversal of deep rocuronium-induced neuromuscular block in adult patients, and the incidence of postoperative adverse events is not increased.