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Safety and efficacy of Ciprofol vs.propofol for sedation in intensive care unit patients with mechanical ventilation:a multi-center,open label,randomized,phase 2 trial

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Chinese Medical Journal 2022年第9期135卷 1043-1051页

作者： Yongjun Liu Xiangyou Yu Duming Zhu Jun Zeng Qinhan Lin Bin Zang Chuanxi Chen Ning Liu Xiao Liu Wei Gao Xiangdong Guan Department of Critical Care Medicine The First Affiliated HospitalSun Yat-sen UniversityGuangzhou 510080China Department of Critical Care Medicine The First Affiliated Hospital of Xinjiang Medical UniversityUrumqi 830011China Department of Critical Care Medicine Zhongshan HospitalFudan UniversityShanghai 200032China Department of Critical Care Medicine Guangzhou First People's HospitalGuangzhou 510180China Department of Critical Care Medicine Qingyuan People's HospitalThe Sixth Affiliated Hospital of Guangzhou Medical UniversityQingyuan 511518China Department of Critical Care Medicine Shengjing Hospital of China Medical UniversityShenyang 110022China Department of Research and Development Haisco Pharmaceutical Group Co.LtdShanghai 201203China.

Background:Ciprofol(HSK3486;Haisco Pharmaceutical Group Co.,Ltd.,Chengdu,China),developed as a novel 2,6-disubstituted phenol derivative showed similar tolerability and efficacy characteristics as propofol when applicated as continuous intravenous infusion for 12 h maintenance sedation in a previous phase 1 trial.The phase 2 trial was designed to investigate the safety,efficacy,and pharmacokinetic characteristics of Ciprofol for sedation of patients undergoing mechanical ventilation.Methods:In this multicenter,open label,randomized,propofol positive-controlled,phase 2 trial,39 Chinese intensive care unit patients receiving mechanical ventilation were enrolled and randomly assigned to a Ciprofol or propofol group in a 2:1 ratio.The Ciprofol infusion was started with a loading infusion of 0.1-0.2 mg/kg for 0.5-5.0 min,followed by an initial maintenance infusion rate of 0.30 mg·kg^(-1)·h^(-1),which could be adjusted to an infusion rate of 0.06 to 0.80 mg·kg^(-1)·h^(-1),whereas for propofol the loading infusion dose was 0.5-1.0 mg/kg for 0.5-5.0 min,followed by an initial maintenance infusion rate of 1.50 mg·kg^(-1)·h^(-1),which could be adjusted to 0.30-4.00 mg·kg^(-1)·h^(-1)to achieve-2 to+1 Richmond Agitation-Sedation Scale sedation within 6-24 h of drug administration.Results:Of the 39 enrolled patients,36 completed the trial.The median(min,max)of the average time to sedation compliance values for Ciprofol and propofol were 60.0(52.6,60.0)min and 60.0(55.2,60.0)min,with median difference of 0.00(95%confidence interval:0.00,0.00).In total,29(74.4%)patients comprising 18(69.2%)in the Ciprofol and 11(84.6%)in the propofol group experienced 86 treatment emergent adverse events(TEAEs),the majority being of severity grade 1 or 2.Drug-and sedation-related TEAEs were hypotension(7.7%vs.23.1%,P=0.310)and sinus bradycardia(3.8%vs.7.7%,P=1.000)in the Ciprofol and propofol groups,respectively.The plasma concentration-time curves for Ciprofol and propofol were similar.Conclusions:Ciprofol is comparable to propofol with good t

关键词： HSK3486 Ciprofol Propofol Sedation Mechanical ventilation

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Anesthesia with Ciprofol in cardiac surgery with cardiopulmonary bypass:A case report

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World Journal of Clinical Cases 2023年第1期11卷 157-163页

作者： Le Yu Evelyne Bischof Hui-Hong Lu Department of Anesthesiology East HospitalTongji University School of MedicineShanghai 200120China Laboratory of Tumor Molecular Biology School of Basic Medical SciencesShanghai University of Medicine and Health SciencesShanghai 201318China Department of Anesthesiology Shanghai East Hospital of Tongji UniversityShanghai 200120China

BACKGROUND Ciprofol is a novel agent for intravenous general anesthesia.In February 2022,it was approved by the National Medical Products Administration for general anesthesia induction and maintenance.It has the advantages of fast onset,fast elimination,stable circulation,and few adverse reactions.However,the efficacy and safety of Ciprofol in cardiac surgery with cardiopulmonary bypass have not been reported.Here we describe a case where Ciprofol was successfully used for anesthesia in cardiac surgery with cardiopulmonary bypass.CASE SUMMARY A 72-year-old man(height 176 cm;weight 70 kg)was diagnosed with coronary atherosclerotic cardiomyopathy requiring coronary artery bypass grafting and left ventricular aneurysmectomy.Ciprofol was administered for induction(0.4 mg/kg)and maintenance(0.6-1.0 mg/kg/h)of general anesthesia.During the entire operation,the bispectral index,hemodynamics,and blood oxygen saturation were maintained at normal levels.The patient recovered well after surgery,with no serious adverse events related to Ciprofol.CONCLUSION Ciprofol is safe and effective for anesthesia in cardiac surgery with cardiopulmonary bypass.

关键词： Ciprofol Coronary artery bypass grafting Left ventricular aneurysmectomy Cardiopulmonary bypass Case report

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Postoperative Sedation Options in ICU

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Journal of Biosciences and Medicines 2024年第1期12卷 93-104页

作者： Cunping Wang Fei Li Emergency and Critical Care Medicine The First Affiliated Hospital of Yangtze University Jingzhou China

This paper examines sedation options in ICU postoperative care. It highlights the necessity of sedation for patients’ physical and mental comfort, safety, and reduction of delirium. The article advocates light sedation, primarily with non-benzodiazepines like propofol or dexmedetomidine, to improve outcomes. It introduces novel sedatives like Ciprofol and remimazolam, suggesting they may be future alternatives in ICU sedation, although more research is needed.

关键词： Light Sedation Remimazolam Ciprofol

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