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奥利瑞丁与舒芬太尼在胃肠内镜检查中的安全性和有效性比较评估:一项单中心随机对照试验

 

Authors Ma B , Li Y, Leng C, Ji A, Zhang N, Tao X, Cao Q, Wang S

Received 16 December 2024

Accepted for publication 5 June 2025

Published 17 June 2025 Volume 2025:19 Pages 5111—5121

DOI https://doi.org/10.2147/DDDT.S512529

Checked for plagiarism Yes

Review by Single anonymous peer review

Peer reviewer comments 2

Editor who approved publication: Professor Mariana Carmen Chifiriuc

Baoyu Ma, Ying Li, Cuibo Leng, Aozhang Ji, Ning Zhang, Xinyi Tao, Qianqian Cao, Shoushi Wang

Department of Anesthesiology and Perioperative Medicine, Qingdao Central Hospital, University of Health and Rehabilitation Sciences (Qingdao Central Medical Group), Qingdao, 266042, People’s Republic of China

Correspondence: Shoushi Wang, Department of Anesthesiology and Perioperative Medicine, Qingdao Central Hospital, University of Health and Rehabilitation Sciences (Qingdao Central Medical Group), Qingdao, 266042, People’s Republic of China, Email wangshoushi@uor.edu.cn

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.

Keywords: oliceridine, sufentanil, procedural sedation, gastrointestinal endoscopy