Drug design, development and therapy · 2025
Estimation of ED50 and ED95 of Oliceridine Required to Suppress the Bronchoscopy Response in Patients Undergoing Fiberoptic Bronchoscopy Under Sedation with Cipepofol: An Up-and-Down Sequential Allocation Trial.
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Wu Dongxue, Liao Yeqing, Qin Yanlin, Wang Yafeng, Xu Bing, Chen Qiuling, Wang Xianting, Wu Xiaoshan, Li Yalan, Guan Xuehai
Аннотация
BACKGROUND: Bronchoscopy response is the main challenge during fiberoptic bronchoscopy (FOB) procedure. Opioids are commonly used to suppress bronchoscopy response. This study aimed to estimate the median effective dose (ED50) of oliceridine for suppressing bronchoscopy response during FOB under deep sedation with cipepofol.
METHODS: This was an up-and-down sequential allocation trial. Patients were divided into male or female groups. The initial bolus of oliceridine was 40 μg/kg. The next dose of oliceridine was determined based on prior patient's response to FOB with 10 μg/kg step size. After seven inflection points were completed, recruitment was terminated. Following a single bolus of oliceridine, all patients received cipepofol (initial bolus:0.4 mg/kg), with infusion rates subsequently titrated between 0.2 and 1.0 mg/kg/h to maintain bispectral index (BIS) values within the 40-60 range. A laryngeal mask (LMA) was inserted when BIS ≤ 60. The endpoints were bronchoscopy response to FOB. Dixon's up-and-down method was used to calculate the ED50 and ED95 of oliceridine required to alleviate the bronchoscopy response. A dose-response curve was generated using probit analysis.
RESULTS: A total of 45 patients (23 males, 22 females) were enrolled in the study. The ED50 of oliceridine for suppressing the response to FOB under cipepofol sedation did not differ between males (median [interquartile range, IQR] 35.00 [35.00 to 36.00] μg/kg) and females (45.00 [35.00 to 45.00] μg/kg) (P=0.0723). Probit analysis showed the ED50 and ED95 of oliceridine required to suppress bronchoscopy response to FOB under deep sedation with cipepofol were 30.20 [95% confidence interval (CI):19.98 to 38.78] vs 40.47 [95% CI: 29.49 to 51.40] μg/kg and 46.49 [95% CI: 38.23 to 105.37] vs 57.55 [95% CI: 48.50 to 141.34] μg/kg in males and females respectively.
CONCLUSION: The ED50 and ED95 of oliceridine required to suppress bronchoscopy response under cipepofol sedation did not differ between males and females.
TRIAL REGISTRATION: Chictr.org.cn; identifier: ChiCTR2400086635.
METHODS: This was an up-and-down sequential allocation trial. Patients were divided into male or female groups. The initial bolus of oliceridine was 40 μg/kg. The next dose of oliceridine was determined based on prior patient's response to FOB with 10 μg/kg step size. After seven inflection points were completed, recruitment was terminated. Following a single bolus of oliceridine, all patients received cipepofol (initial bolus:0.4 mg/kg), with infusion rates subsequently titrated between 0.2 and 1.0 mg/kg/h to maintain bispectral index (BIS) values within the 40-60 range. A laryngeal mask (LMA) was inserted when BIS ≤ 60. The endpoints were bronchoscopy response to FOB. Dixon's up-and-down method was used to calculate the ED50 and ED95 of oliceridine required to alleviate the bronchoscopy response. A dose-response curve was generated using probit analysis.
RESULTS: A total of 45 patients (23 males, 22 females) were enrolled in the study. The ED50 of oliceridine for suppressing the response to FOB under cipepofol sedation did not differ between males (median [interquartile range, IQR] 35.00 [35.00 to 36.00] μg/kg) and females (45.00 [35.00 to 45.00] μg/kg) (P=0.0723). Probit analysis showed the ED50 and ED95 of oliceridine required to suppress bronchoscopy response to FOB under deep sedation with cipepofol were 30.20 [95% confidence interval (CI):19.98 to 38.78] vs 40.47 [95% CI: 29.49 to 51.40] μg/kg and 46.49 [95% CI: 38.23 to 105.37] vs 57.55 [95% CI: 48.50 to 141.34] μg/kg in males and females respectively.
CONCLUSION: The ED50 and ED95 of oliceridine required to suppress bronchoscopy response under cipepofol sedation did not differ between males and females.
TRIAL REGISTRATION: Chictr.org.cn; identifier: ChiCTR2400086635.