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

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).