A Comparative Evaluation of the Safety and Efficacy of Oliceridine and Sufentanil in Gastrointestinal Endoscopy: A Single-Center, Randomized Controlled Trial
Abstract
Purpose Gastrointestinal (GI) endoscopic sedation employs a range of medication regimens; however, safer and more effective sedation protocols must be identified. Oliceridine, a novel biased µ-opioid receptor agonist, can reduce opioid-related adverse events. However, compared to traditional opioids, data on its use in GI endoscopic sedation remain limited. Patients and Methods This single-center, randomized controlled clinical trial was conducted between April and July 2024. In total, 628 patients scheduled for GI endoscopy were randomly assigned to receive either remimazolam-etomidate-oliceridine or remimazolam-etomidate-sufentanil for sedation. The primary outcome was the incidence of respiratory depression, and the secondary outcomes included the incidence of hypoxemia, need for airway intervention, procedure- and sedation-related metrics, sedation success rate, and adverse events. Results Among the 628 patients, 305 and 307 were randomized in the oliceridine and sufentanil groups, respectively, and completed the trial. Respiratory depression occurred in 43 patients (14.1%) in the oliceridine group compared to 67 patients (21.8%) in the sufentanil group (odds ratio, 0.59; 95% CI, 0.39–0.90; p=0.013). No significant differences were observed in the incidence of hypoxemia between the groups; however, the need for airway intervention was significantly higher in the sufentanil group (p<0.001). The sedation success rates were 99.7% and 100% in the oliceridine and sufentanil…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 628 participants or records.
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