Abstract
PURPOSE: To compare the effects of oxycodone versus sufentanil on postoperative pulmonary complications (PPCs) in patients with preoperative pulmonary dysfunction undergoing laparoscopic gastrointestinal surgery. METHODS: This single-center, double-blind, randomized, parallel controlled trial was conducted at the First Affiliated Hospital of Ningbo University in Ningbo, China. A total of 142 patients with preoperative pulmonary dysfunction who were scheduled to receive elective laparoscopic gastrointestinal surgery (including Da Vinci robot-assisted surgery) were enrolled between June 6, 2024, to June 30, 2025. Patients were randomized to receive intraoperative oxycodone (0.2 mg/kg) or sufentanil (0.4 µg/kg) during anesthesia induction, and oxycodone 0.1 mg/kg/sufentanil 0.2 µg /kg thirty minutes prior to the end of surgery, followed by PCIA with oxycodone (0.5 mg/kg diluted to 100 mL) or sufentanil (1 µg/kg diluted to 100 mL), with a background infusion of 2 mL/h, bolus 2 mL, and lockout 15 min. The primary outcome was the incidence of PPCs within 30 days after surgery. RESULTS: Among 142 patients enrolled, 71 were randomized to receive intraoperative oxycodone, and 71 were randomized to receive sufentanil. In total, 7 patients were excluded and 135 patients were included in the ITT analysis. The incidence rate of PPCs was significantly lower in the oxycodone group compared to the sufentanil group (38.2% [26 of 68] vs. 56.7% [38 of 67]; relative risk = 0.67 [95% CI, 0.47 to 0.97]; P < 0.05). The incidence of PONV was also lower in the oxycodone group (16.2% vs 32.8%; relative risk = 0.49 [95% CI, 0.26 to 0.94]; P < 0.05). Pain scores at each time point and Opioid consumption within 48 h postoperatively were comparable between the oxycodone group and the sufentanil group. No statistically significant differences were observed between the two groups regarding postoperative rehabilitation metrics, including time to first flatus and length of hospital stay. CONCLUSIONS: Compared with sufentanil, oxycodone significantly reduced PPCs incidence in high-risk patients with pulmonary dysfunction without compromising analgesia or recovery, suggesting its utility in perioperative lung-protective strategies. TRIAL REGISTRATION: Registration number: ChiCTR2500099262. Registration date: March 20, 2025(Retrospectively registered).