Drug design, development and therapy · 2025
Determine of 90% Effective Dose of Oliceridine Combined with Etomidate for Inhibiting Laryngeal Mask Airway Insertion Responses in Patients of Different Ages: A Biased-Coin Sequential Allocation Dose-Finding Trial.
СтатьяРандомизированное исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Xu Fangsheng, Cui Yuanyuan, Wang Zhengle, Liu Rongguang, Tang Jian, Xu Yuan, Li Luoyun, Li Chunyu, Wang Meifang, Pu Jianfeng
Аннотация
BACKGROUND: Oliceridine is a μ-opioid receptor agonist that selectively activates the G-protein signaling pathway, offering a potential advantage over traditional opioids by reducing respiratory depression and gastrointestinal reactions. This study aimed to determine the 90% effective dose (ED90) of oliceridine for inhibiting responses to laryngeal mask airway (LMA) insertion under etomidate anesthesia in patients of different ages.
METHODS: This prospective Biased-Coin Sequential Allocation Dose-Finding Trial initially enrolled 120 patients scheduled for LMA anesthesia, divided into two age groups: young-to-middle-aged (Group A, 18-64 years) and elderly (Group B, 65-79 years). The initial dose of oliceridine was 0.02 mg/kg, with dose spacing of 0.002 mg/kg. Dose adjustments for subsequent patients were based on the previous subject's response. If movement, frowning, tearing, coughing, or hemodynamic parameters exceeding 20% above baseline occurred during LMA insertion, the dose was considered inadequate, and the dose for the next patient was increased. Otherwise, biased-coin randomization was applied to the next patient, with an 89% probability of maintaining the same dose and an 11% probability of reducing the dose. The primary outcome was the ED90 and 95% confidence intervals (CIs) for oliceridine combined with etomidate in inhibiting responses to LMA insertion.
RESULTS: A total of 113 patients met the study criteria and were included in the final analysis (58 in the group A and 55 in the group B). The ED90 of Oliceridine was 0.0246 mg/kg (95% CI: 0.0215-0.0320 mg/kg) and 0.0229 mg/kg (95% CI: 0.0199-0.0298 mg/kg), respectively. No significant difference in ED90 was observed between the two groups (P > 0.05).
CONCLUSION: The ED90 of oliceridine for inhibiting LMA insertion responses, when combined with 0.25 mg/kg etomidate, was 0.0246 mg/kg in young-to-middle-aged patients and 0.0229 mg/kg in elderly patients.
TRIAL REGISTRATION: The study was registered with the Chinese Clinical Trial Registry (ChiCTR2500095893) on January 25, 2025.
METHODS: This prospective Biased-Coin Sequential Allocation Dose-Finding Trial initially enrolled 120 patients scheduled for LMA anesthesia, divided into two age groups: young-to-middle-aged (Group A, 18-64 years) and elderly (Group B, 65-79 years). The initial dose of oliceridine was 0.02 mg/kg, with dose spacing of 0.002 mg/kg. Dose adjustments for subsequent patients were based on the previous subject's response. If movement, frowning, tearing, coughing, or hemodynamic parameters exceeding 20% above baseline occurred during LMA insertion, the dose was considered inadequate, and the dose for the next patient was increased. Otherwise, biased-coin randomization was applied to the next patient, with an 89% probability of maintaining the same dose and an 11% probability of reducing the dose. The primary outcome was the ED90 and 95% confidence intervals (CIs) for oliceridine combined with etomidate in inhibiting responses to LMA insertion.
RESULTS: A total of 113 patients met the study criteria and were included in the final analysis (58 in the group A and 55 in the group B). The ED90 of Oliceridine was 0.0246 mg/kg (95% CI: 0.0215-0.0320 mg/kg) and 0.0229 mg/kg (95% CI: 0.0199-0.0298 mg/kg), respectively. No significant difference in ED90 was observed between the two groups (P > 0.05).
CONCLUSION: The ED90 of oliceridine for inhibiting LMA insertion responses, when combined with 0.25 mg/kg etomidate, was 0.0246 mg/kg in young-to-middle-aged patients and 0.0229 mg/kg in elderly patients.
TRIAL REGISTRATION: The study was registered with the Chinese Clinical Trial Registry (ChiCTR2500095893) on January 25, 2025.