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Evidence-Based Supplement Research
Evidence-Based Supplement Research

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 106
Population
96 patients undergoing laparoscopic radical gastrectomy
Methods
Randomized double-blind controlled trial, oliceridine vs sufentanil for patient-controlled intravenous analgesia
Blinding
Double-blind
Funding
Unclear
  • Large Human Trial

Background

Postoperative ileus and opioid-related side effects are major barriers to recovery following laparoscopic gastrectomy. Oliceridine, a novel G-protein-biased μ-opioid receptor agonist, aims to offer effective analgesia with fewer adverse effects. This study evaluated the efficacy of oliceridine for patient-controlled intravenous analgesia (PCIA) on gastrointestinal (GI) recovery and analgesic outcomes.

Methods

This single-center, prospective, randomized, double-blind, controlled trial enrolled 106 patients undergoing elective laparoscopic radical gastrectomy. Participants were randomized to receive either sufentanil (Group S, 1.5 µg/kg) or oliceridine (Group O, 0.35 mg/kg) for PCIA. The primary outcome was time to first flatus. Secondary outcomes included time to first defecation, I-FEED scores, Visual Analog Scale (VAS) scores, Richmond Agitation-Sedation Scale (RASS) scores, incidence of adverse events, and postoperative length of stay (LOS).

Results

A total of 96 patients were included in the final analysis. Both groups demonstrated comparable analgesic efficacy, with no significant differences in VAS scores over 48 hours. However, the oliceridine group exhibited significantly faster GI recovery, including shorter times to first flatus (52.9 vs 59.2 hours) and first defecation (82.0 vs 93.0 hours). Patients in the oliceridine group also had lower I-FEED scores and resumed oral intake significantly faster. Oliceridine significantly reduced the incidence of nausea (10.2% vs 25.5%) and vomiting (4.1% vs 21.3%) compared to sufentanil. This group also demonstrated a calmer emergence profile, earlier first ambulation, and a significantly shorter postoperative LOS [11 (10, 12) vs 12 (10, 14) days]. No respiratory depression was observed in either cohort.

Conclusion

In patients undergoing laparoscopic radical gastrectomy, oliceridine-based PCIA provides analgesic efficacy comparable to sufentanil but significantly accelerates gastrointestinal function recovery, improves emergence quality, reduces the incidence of postoperative nausea and vomiting, and shortens hospital stay. It represents a valuable analgesic strategy for Enhanced Recovery After Surgery (ERAS) protocols.

Trial registration

Chinese Clinical Trial Registry. Identifier: ChiCTR2500095364.

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