Drug design, development and therapy · 2026
Safety and Efficacy of Oliceridine Combined with Propofol for Painless Gastroscopy: A Single-Center, Randomized, Parallel Controlled Clinical Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод в очереди
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Hu Xuping, Yang Chunyuan, Li Jun, Wang Fuping, You Hongjiang, Chen Changchun, Jiang Leyu
Аннотация
PURPOSE: To explore the safety and efficacy of the novel G protein-biased μ-opioid receptor agonist oliceridine for painless gastroscopy.
METHODS: This study is a single-center randomized controlled clinical trial. One hundred and eighty-eight patients scheduled for painless gastroscopy were randomly assigned to four groups: Group L (oliceridine 10 μg/kg + propofol 2mg/kg), Group M (oliceridine 20 μg/kg + propofol 2mg/kg), Group H (oliceridine 30 μg/kg + propofol 2mg/kg) and Group C (sufentanil 0.1 μg/kg + propofol 2mg/kg). The primary outcome was the incidence of respiratory depression. Secondary outcomes included the incidence of respiratory arrest, bradypnea (respiratory rate<8 bpm) and hypoxemia (pulse oxygen saturation (SpO2) < 90%). Other outcomes included procedure and sedation-related outcomes, perioperative vital signs and adverse effects were recorded.
RESULTS: Among the 184 patients, 46, 46, 45 and 47 patients were randomly assigned to the L, M, H and C groups, respectively, and completed the trial. The incidence of respiratory depression in Group C (55.32%) and Group H (46.67%) was significantly higher than that in Group L (15.22%) and Group M (17.39%) (P<0.05). The incidence of respiratory arrest was higher in group H (42.22%) and group C (51.06%) compared to group L (13.04%) and group M (15.22%) (P < 0.05). The incidence of bradypnea and hypoxemia in group C (31.90% and 14.89%) was higher than that in group M (6.5% and 0) (P < 0.05). The sedation success rate was significantly lower in Group L than in Group M (71.74% vs 93.48%; P < 0.05). No significant differences were observed in the incidence of postoperative adverse effects.
CONCLUSION: 10 μg/kg and 20 μg/kg oliceridine is associated with a reduced risk of respiratory depression when co-administered with propofol for painless gastroscopy in adults, and the 20 μg/kg oliceridine exhibits superior sedative efficacy.
METHODS: This study is a single-center randomized controlled clinical trial. One hundred and eighty-eight patients scheduled for painless gastroscopy were randomly assigned to four groups: Group L (oliceridine 10 μg/kg + propofol 2mg/kg), Group M (oliceridine 20 μg/kg + propofol 2mg/kg), Group H (oliceridine 30 μg/kg + propofol 2mg/kg) and Group C (sufentanil 0.1 μg/kg + propofol 2mg/kg). The primary outcome was the incidence of respiratory depression. Secondary outcomes included the incidence of respiratory arrest, bradypnea (respiratory rate<8 bpm) and hypoxemia (pulse oxygen saturation (SpO2) < 90%). Other outcomes included procedure and sedation-related outcomes, perioperative vital signs and adverse effects were recorded.
RESULTS: Among the 184 patients, 46, 46, 45 and 47 patients were randomly assigned to the L, M, H and C groups, respectively, and completed the trial. The incidence of respiratory depression in Group C (55.32%) and Group H (46.67%) was significantly higher than that in Group L (15.22%) and Group M (17.39%) (P<0.05). The incidence of respiratory arrest was higher in group H (42.22%) and group C (51.06%) compared to group L (13.04%) and group M (15.22%) (P < 0.05). The incidence of bradypnea and hypoxemia in group C (31.90% and 14.89%) was higher than that in group M (6.5% and 0) (P < 0.05). The sedation success rate was significantly lower in Group L than in Group M (71.74% vs 93.48%; P < 0.05). No significant differences were observed in the incidence of postoperative adverse effects.
CONCLUSION: 10 μg/kg and 20 μg/kg oliceridine is associated with a reduced risk of respiratory depression when co-administered with propofol for painless gastroscopy in adults, and the 20 μg/kg oliceridine exhibits superior sedative efficacy.