Tegileridine vs. sufentanil for postoperative analgesia in general surgery: A prospective, randomized, controlled, non-inferiority trial.

Objective

Tegileridine, a novel G protein-biassed μ-opioid receptor agonist, may offer effective postoperative analgesia with fewer opioid-related adverse effects. This study evaluated its analgesic efficacy, safety and impact on surgical stress response vs. sufentanil for patient-controlled intravenous analgesia (PCIA) in general surgery patients.

Methods

In this single-centre, double-blind, non-inferiority trial, 120 adults scheduled for elective laparoscopic cholecystectomy, appendectomy or inguinal hernia repair were randomized 1:1 to 48-h PCIA with tegileridine (5 mg) or sufentanil (200 μg), both with tropisetron 10 mg. The primary outcome was 24-h area under the curve (AUC) for resting visual analogue scale (VAS) pain scores, with a non-inferiority margin of 10.6 points·h. Secondary outcomes included pain scores, PCIA usage, adverse events, recovery and plasma cortisol and interleukin-6 (IL-6).

Results

All 120 patients completed the study. Mean 24-h resting VAS-AUC was 102.3 ± 25.6 points·h (tegileridine) vs. 105.8 ± 27.1 points·h (sufentanil). Upper 97.5% confidence limit for the difference was 9.8 points·h, below the 10.6 margin (p < .001). Tegileridine significantly reduced postoperative nausea and vomiting (p = .007) and accelerated gastrointestinal recovery (p < .001). Postoperative cortisol and IL-6 elevations were significantly attenuated at 6 and 24 h (p < .001). No significant differences were observed for other adverse events or satisfaction.

Conclusion

Tegileridine provides non-inferior analgesia to sufentanil FOR PCIA after general surgery, with reduced PONV, faster gastrointestinal recovery and blunted stress response, supporting its potential role in enhanced recovery protocols. TRIAL REGISTRATION Chinese Clinical Trial Registry (ChiCTR2500114360).