Efficacy and safety of oliceridine versus sufentanil for patient-controlled intravenous analgesia following gynecological laparoscopic surgery: a randomized, double-blind, parallel-group trial.

BACKGROUND: To compare the efficacy and incidence of adverse reactions of oliceridine versus sufentanil in patient-controlled intravenous analgesia (PCIA) for postoperative pain management following gynecological laparoscopic surgery. METHODS: In this randomized, double-blind trial, 152 patients undergoing elective gynecological laparoscopic surgery were randomly assigned to receive PCIA with either oliceridine (Group O, 0.4 mg/kg, n = 76) or sufentanil (Group S, 2 μg/kg, n = 76). The primary outcome was the Visual Analog Scale (VAS) score at rest at 2, 4, 8, 12, 18, 24, 36, and 48 h postoperatively. Secondary outcomes included postoperative Mini-Mental State Examination (MMSE) scores, number of PCIA demands, rescue analgesic use, adverse events, time to first flatus and defecation, patient satisfaction, and length of hospital stay. RESULTS: Resting VAS scores were comparable between groups except at 4 h (p < 0.05). No significant differences were observed in MMSE scores, PCIA demands, rescue analgesia, time to first defecation, or other adverse events (pruritus, dizziness, fever, headache, cough, and abdominal distension) (all p > 0.05). Group O had higher body weight and body mass index (BMI) than Group S (p = 0.028 and p = 0.041, respectively). Group O demonstrated lower postoperative nausea and vomiting (PONV) incidence (19.48% vs. 36.14%; relative risk (RR), 0.54; 95% confidence interval (CI), 0.32-0.92; p = 0.019), prolonged time to first flatus (27.16 ± 9.33 h vs. 23.23 ± 9.36 h; p = 0.014), and higher patient satisfaction (4.09 ± 0.81 vs. 3.74 ± 0.72; p = 0.006). CONCLUSION: For postoperative analgesia following gynecological laparoscopic surgery, oliceridine provides effective analgesia comparable to sufentanil while significantly reducing the risk of opioid-related PONV, demonstrating a favorable safety profile. CLINICAL TRIAL REGISTRATION: http://www.chictr.org.cn/, ChiCTR2400089648.