Oliceridine versus Sufentanil on Postoperative Nausea and Vomiting in Women Undergoing Gynecological Laparoscopic Surgery: A Randomized Double‑Blind Controlled Trial.
Аннотация
PURPOSE: To evaluate whether oliceridine, a G protein-biased μ-opioid receptor agonist, reduces postoperative nausea and vomiting (PONV) compared with sufentanil in women undergoing gynecological laparoscopic surgery.
PATIENTS AND
METHODS
This prospective, double-blind, randomized controlled trial recruited 260 female patients, ASA physical status I-III, undergoing elective gynecological laparoscopic surgery under general anesthesia at Shanghai East Hospital, Shanghai, People's Republic of China. Patients were randomized to receive oliceridine (induction 0.05 mg/kg; postoperative infusion 0.4 mg/kg) or sufentanil (induction 0.5 μg/kg; postoperative infusion 2.0 μg/kg), with standardized general anesthesia and prophylactic antiemetics. The primary outcome was 48-hour cumulative PONV incidence. Secondary outcomes included PONV severity, opioid-induced respiratory depression (OIRD), adverse events, pain scores, 15-item Quality of Recovery (QoR-15) score, and patient satisfaction. All analyses were performed on the modified intention-to-treat population.
RESULTS
The 48-hour PONV incidence was significantly lower with oliceridine (22.5% vs 43.0%; odds ratio 0.38; 95% CI 0.22-0.66; P < 0.001), with consistent findings after multivariate adjustment. The absolute risk reduction was 20.5%, with a relative risk of 0.52, and a number needed to treat of 5, representing a clinically meaningful antiemetic advantage. Severe PONV was reduced (3.9% vs 15.6%, q = 0.02). No significant differences were observed in pain scores or rescue analgesia. Oliceridine patients reported higher QoR-15 scores (median 123 vs 116, q = 0.002) and greater satisfaction (69.0% vs 50.8%, q = 0.02). OIRD and dizziness trended lower but were not significant after multiplicity correction.
CONCLUSION
Oliceridine significantly reduced PONV incidence and improved recovery quality and patient satisfaction compared with sufentanil, without compromising analgesia, in women undergoing gynecological laparoscopic surgery.
Предметные рубрики MeSH
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Обработка статьи · этапы, ошибки и управление
Ошибки и ограничения
История · было → стало
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