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已发表论文
不同年龄段患者中奥利瑞丁联合依托咪酯抑制喉罩置入反应的90%有效剂量测定：一项偏币序贯分配剂量探索试验
Authors Xu F , Cui Y, Wang Z, Liu R , Tang J, Xu Y, Li L, Li C, Wang M, Pu J
Received 26 June 2025
Accepted for publication 13 November 2025
Published 20 November 2025 Volume 2025:19 Pages 10259—10268
DOI https://doi.org/10.2147/DDDT.S549813
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 2
Editor who approved publication: Professor Anastasios Lymperopoulos
Fangsheng Xu,1,* Yuanyuan Cui,2,* Zhengle Wang,1 Rongguang Liu,1 Jian Tang,1 Yuan Xu,1 Luoyun Li,3 Chunyu Li,4 Meifang Wang,1 Jianfeng Pu1
1Department of Anesthesiology, Changshu No. 2 People’s Hospital, Changshu, People’s Republic of China; 2Department of Anesthesiology, Affiliated Changshu Hospital of Nanjing University of Chinese Medicine, Changshu, People’s Republic of China; 3Neurology Intensive Care Unit, Department of Neurology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, People’s Republic of China; 4Department of Anesthesiology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Meifang Wang, Email 2003wmf@163.com Jianfeng Pu, Email Pjh61255397@163.com
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.
Plain Language Summary: Determining the optimal drug dose that balances effectiveness and safety is a central challenge in anesthesia research. Adaptive dose-finding methods, such as the biased-coin up-and-down design, allow researchers to estimate effective doses efficiently while exposing fewer patients to suboptimal levels. In this prospective trial, we investigated oliceridine, a novel μ-opioid receptor agonist that preferentially activates G-protein signaling and may cause fewer respiratory and gastrointestinal side effects than traditional opioids. The study aimed to identify the 90% effective dose (ED90) of oliceridine required to suppress patient reactions during laryngeal mask airway (LMA) insertion under etomidate anesthesia in adults of different ages. The results demonstrate that oliceridine combined with etomidate provides consistent suppression of airway reflexes and stable anesthesia induction in both younger and older adults. These findings support its role as a safe, precise, and modern opioid adjunct for balanced anesthesia practice.
Keywords: oliceridine, 90% effective dose, biased coin design, mask airway insertion response, elderly patients
1Department of Anesthesiology, Changshu No. 2 People’s Hospital, Changshu, People’s Republic of China; 2Department of Anesthesiology, Affiliated Changshu Hospital of Nanjing University of Chinese Medicine, Changshu, People’s Republic of China; 3Neurology Intensive Care Unit, Department of Neurology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, People’s Republic of China; 4Department of Anesthesiology, Heping Hospital Affiliated to Changzhi Medical College, Changzhi, People’s Republic of China
*These authors contributed equally to this work
Correspondence: Meifang Wang, Email 2003wmf@163.com Jianfeng Pu, Email Pjh61255397@163.com
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.
Plain Language Summary: Determining the optimal drug dose that balances effectiveness and safety is a central challenge in anesthesia research. Adaptive dose-finding methods, such as the biased-coin up-and-down design, allow researchers to estimate effective doses efficiently while exposing fewer patients to suboptimal levels. In this prospective trial, we investigated oliceridine, a novel μ-opioid receptor agonist that preferentially activates G-protein signaling and may cause fewer respiratory and gastrointestinal side effects than traditional opioids. The study aimed to identify the 90% effective dose (ED90) of oliceridine required to suppress patient reactions during laryngeal mask airway (LMA) insertion under etomidate anesthesia in adults of different ages. The results demonstrate that oliceridine combined with etomidate provides consistent suppression of airway reflexes and stable anesthesia induction in both younger and older adults. These findings support its role as a safe, precise, and modern opioid adjunct for balanced anesthesia practice.
Keywords: oliceridine, 90% effective dose, biased coin design, mask airway insertion response, elderly patients