Drug design, development and therapy · 2025
A Comparative Evaluation of the Safety and Efficacy of Oliceridine and Sufentanil in Gastrointestinal Endoscopy: A Single-Center, Randomized Controlled Trial.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Ma Baoyu, Li Ying, Leng Cuibo, Ji Aozhang, Zhang Ning, Tao Xinyi, Cao Qianqian, Wang Shoushi
Аннотация
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 groups, respectively. Additionally, the oliceridine group demonstrated lower incidence of hypotension (11.8% vs 18.2%, p=0.026), postoperative nausea and vomiting (4.6% vs 10.1%, p=0.009), and higher patient satisfaction scores (9 [9,9] vs 9 [8,9], p=0.003).
CONCLUSION: The sedation success rate for GI endoscopy using remimazolam and etomidate in combination with either oliceridine or sufentanil approaches 100%, with oliceridine demonstrating superior safety and enhanced patient satisfaction.
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 groups, respectively. Additionally, the oliceridine group demonstrated lower incidence of hypotension (11.8% vs 18.2%, p=0.026), postoperative nausea and vomiting (4.6% vs 10.1%, p=0.009), and higher patient satisfaction scores (9 [9,9] vs 9 [8,9], p=0.003).
CONCLUSION: The sedation success rate for GI endoscopy using remimazolam and etomidate in combination with either oliceridine or sufentanil approaches 100%, with oliceridine demonstrating superior safety and enhanced patient satisfaction.