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Aim <p>To determine the median effective dose of ciprofol for anesthesia induction in patients undergoing cardiac valve replacement and to evaluate its safety.</p> Methods <p>Twenty-seven patients with heart valve disease (HVD), aged 18–64 years with a BMI of 15–28&#xa0;kg/m² and classified as American Society of Anesthesiologists (ASA) physical status II or III, were enrolled. The effective dose of ciprofol was determined using Dixon’s up-and-down method, starting from an initial dose of 0.30&#xa0;mg/kg with an increment of 0.02&#xa0;mg/kg. A probit model was employed to calculate the ED50 and ED95. Hemodynamic parameters, including heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO₂), and the bispectral index (BIS), were recorded at baseline and every minute for 5&#xa0;min following drug administration. The incidence of adverse events, such as hypotension, bradycardia, respiratory depression, and injection pain, was also documented.</p> Results <p>The Median Effective Dose (ED) 50 (with 95% confidence intervals, CIs) for ciprofol-induced loss of consciousness were 0.307&#xa0;mg/kg (95% CI: 0.272–0.358&#xa0;mg/kg) and the ED95 was 0.366&#xa0;mg/kg (95% CI: 0.334–0.938&#xa0;mg/kg), reflecting inherent limitations of the up-and-down method when estimating upper quantiles. Hypotension occurred in 15% of patients, and respiratory depression was observed in 26%. No patients experienced injection pain, hypoxemia, or clinically significant bradycardia.</p> Conclusion <p>For anesthesia induction in patients with HVD, the ED50 and ED95 of a single intravenous dose of ciprofol were 0.307&#xa0;mg/kg and 0.366&#xa0;mg/kg, respectively. Ciprofol was associated with a low incidence of anesthesia-related adverse events, suggesting it is a suitable agent for anesthesia induction in patients undergoing cardiac surgery.</p> Trial registration <p><a href="http://www.chictr.org.cn">http://www.chictr.org.cn</a> (ChiCTR2300071427, 15/5/2023).</p>

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Exploring the median effective dose of ciprofol for anesthesia induction in patients with heart valve disease: a prospective, single-arm, single-centre study

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年2月27日

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  • Qi Mao,
  • Beiwei Liang,
  • Yizhi Lu,
  • Danfeng Luo,
  • Fang He,
  • Lifang Zhou,
  • Guofeng Liu,
  • Yanhua Chen,
  • Yubo Xie

摘要

Aim

To determine the median effective dose of ciprofol for anesthesia induction in patients undergoing cardiac valve replacement and to evaluate its safety.

Methods

Twenty-seven patients with heart valve disease (HVD), aged 18–64 years with a BMI of 15–28 kg/m² and classified as American Society of Anesthesiologists (ASA) physical status II or III, were enrolled. The effective dose of ciprofol was determined using Dixon’s up-and-down method, starting from an initial dose of 0.30 mg/kg with an increment of 0.02 mg/kg. A probit model was employed to calculate the ED50 and ED95. Hemodynamic parameters, including heart rate (HR), mean arterial pressure (MAP), peripheral oxygen saturation (SpO₂), and the bispectral index (BIS), were recorded at baseline and every minute for 5 min following drug administration. The incidence of adverse events, such as hypotension, bradycardia, respiratory depression, and injection pain, was also documented.

Results

The Median Effective Dose (ED) 50 (with 95% confidence intervals, CIs) for ciprofol-induced loss of consciousness were 0.307 mg/kg (95% CI: 0.272–0.358 mg/kg) and the ED95 was 0.366 mg/kg (95% CI: 0.334–0.938 mg/kg), reflecting inherent limitations of the up-and-down method when estimating upper quantiles. Hypotension occurred in 15% of patients, and respiratory depression was observed in 26%. No patients experienced injection pain, hypoxemia, or clinically significant bradycardia.

Conclusion

For anesthesia induction in patients with HVD, the ED50 and ED95 of a single intravenous dose of ciprofol were 0.307 mg/kg and 0.366 mg/kg, respectively. Ciprofol was associated with a low incidence of anesthesia-related adverse events, suggesting it is a suitable agent for anesthesia induction in patients undergoing cardiac surgery.

Trial registration

http://www.chictr.org.cn (ChiCTR2300071427, 15/5/2023).