Drug design, development and therapy · 2026
Effect of Propofol Combined with Oliceridine versus Fentanyl on Desaturation During Gastrointestinal Endoscopy: A Randomized Clinical Trial.
Сравнительное исследованиеСтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Xu Fangsheng, Cui Yuanyuan, Wang Qian, Tang Jian, Xu Yuan, Liu Rongguang, Wang Zhengle, Zhang Wei, Wu Feng, Ma Shuyu, Wang Mincong, Liu Mengqi, Pu Jianfeng, Wang Meifang, Huang Ye
Аннотация
BACKGROUND: Propofol combined with fentanyl is widely used for gastrointestinal endoscopy sedation but may be associated with oxygen desaturation. Oliceridine, a G protein-biased μ-opioid receptor agonist, may have fewer opioid-related respiratory effects. We compared propofol-oliceridine with propofol-fentanyl for desaturation during gastrointestinal endoscopy.
METHODS: This single-center, double-blind, randomized clinical trial was conducted at Changshu No. 2 People's Hospital, China. Adults aged 18-65 years with ASA physical status I-II undergoing bidirectional gastrointestinal endoscopy were randomized 1:1 to receive propofol combined with either oliceridine 20 μg/kg or fentanyl 1 μg/kg. The primary outcome was mild desaturation, defined as SpO2 <95%. Exploratory secondary outcomes included severe desaturation, SpO2 <90%, airway interventions, hypotension, bradycardia, recovery-related adverse events, and satisfaction scores.
RESULTS: Among 228 randomized patients, 224 were included in the modified intention-to-treat analysis. Mild desaturation occurred in 18 of 112 patients in the oliceridine group and 30 of 112 patients in the fentanyl group (16.1% vs 26.8%; unadjusted OR, 0.52; 95% CI, 0.27-1.01; P=0.053; adjusted OR, 0.49; 95% CI, 0.24-0.997; P=0.049). A full intention-to-treat sensitivity analysis including all randomized patients yielded consistent adjusted results (adjusted OR, 0.47; 95% CI, 0.23-0.95; P=0.035). Severe desaturation and airway intervention did not differ significantly between groups. Compared with the fentanyl group, the oliceridine group had lower incidences of SBP <90 mmHg, SBP <80 mmHg, and vasopressor use. Initial sedation success and intra-procedural MOAA/S sedation depth were comparable between groups.
CONCLUSION: In this randomized clinical trial of patients undergoing bidirectional gastrointestinal endoscopy, propofol-oliceridine may reduce mild desaturation and hypotension compared with propofol-fentanyl while maintaining comparable intra-procedural sedation depth.
TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2500096869.
METHODS: This single-center, double-blind, randomized clinical trial was conducted at Changshu No. 2 People's Hospital, China. Adults aged 18-65 years with ASA physical status I-II undergoing bidirectional gastrointestinal endoscopy were randomized 1:1 to receive propofol combined with either oliceridine 20 μg/kg or fentanyl 1 μg/kg. The primary outcome was mild desaturation, defined as SpO2 <95%. Exploratory secondary outcomes included severe desaturation, SpO2 <90%, airway interventions, hypotension, bradycardia, recovery-related adverse events, and satisfaction scores.
RESULTS: Among 228 randomized patients, 224 were included in the modified intention-to-treat analysis. Mild desaturation occurred in 18 of 112 patients in the oliceridine group and 30 of 112 patients in the fentanyl group (16.1% vs 26.8%; unadjusted OR, 0.52; 95% CI, 0.27-1.01; P=0.053; adjusted OR, 0.49; 95% CI, 0.24-0.997; P=0.049). A full intention-to-treat sensitivity analysis including all randomized patients yielded consistent adjusted results (adjusted OR, 0.47; 95% CI, 0.23-0.95; P=0.035). Severe desaturation and airway intervention did not differ significantly between groups. Compared with the fentanyl group, the oliceridine group had lower incidences of SBP <90 mmHg, SBP <80 mmHg, and vasopressor use. Initial sedation success and intra-procedural MOAA/S sedation depth were comparable between groups.
CONCLUSION: In this randomized clinical trial of patients undergoing bidirectional gastrointestinal endoscopy, propofol-oliceridine may reduce mild desaturation and hypotension compared with propofol-fentanyl while maintaining comparable intra-procedural sedation depth.
TRIAL REGISTRATION: Chinese Clinical Trial Registry: ChiCTR2500096869.