Oliceridine versus Sufentanil for Postoperative Intravenous Analgesia in Patients Undergoing Abdominal Surgery in the AICU: A Double-Blind Non-Inferiority Trial.
Аннотация
OBJECTIVE
To compare the efficacy of Oliceridine and sufentanil in postoperative pain management, adverse reactions, and their effects on extubation in patients undergoing abdominal surgery in an anaesthesia intensive care unit (AICU).
METHODS
This study was a randomised controlled non-inferiority clinical trial conducted between November 2024 and October 2025. It enrolled 184 patients transferred to the AICU following abdominal surgery, who were randomly assigned to Group S (100 μg sufentanil) or Group O (20 mg Oliceridine). In both groups, the analgesic pumps were diluted with normal saline to 100 mL, and patient-controlled intravenous analgesia (PCIA) was administered following transfer to the AICU; the primary outcome was the NRS score 6 hours after extubation, whilst secondary outcomes included resting NRS scores at various time points, the Ramsay sedation score, adverse reactions, the number of pump pushes, level of consciousness, time to extubation, and haemodynamic changes at the time of extubation.
RESULTS
The 6-hour NRS score in the Oliceridine group was non-inferior to that in the sufentanil group (1.63 ± 0.60 vs 1.75 ± 0.58; 95% CI upper limit 0.06, which is below the pre-specified non-inferiority margin of 0.6). There were no statistically significant differences at any time point in resting NRS, Ramsay score, time to awakening/extubation, haemodynamics, or analgesic pump usage (P > 0.05). Regarding adverse events, the incidence of nausea in the Oliceridine group (9.6%) was significantly lower than that in the sufentanil group (24.1%) (P < 0.05); there were no differences in the incidence of other adverse events.
CONCLUSION
Among patients undergoing abdominal surgery at the AICU, the use of Oliceridine for postoperative analgesia was non-inferior to sufentanil and was associated with a lower incidence of postoperative nausea.
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