drugset / Trial / NCT05881291

Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement

NCT05881291

RandomizedParallel-groupDouble-blindTreatment

Summary

Aortic valve stenosis is the most common debilitating valvular heart lesion in old patients. Transcatheter aortic valve replacement (TAVR) is an emergent technique for high-risk patients with aortic stenosis. In recent times, treatment has expanded to also include low- and intermediate-risk individuals. General anesthesia offers many advantages, mainly regarding the possibility of an early diagnosis and treatment of possible complications through the use of transesophageal echocardiography. Propofol is the most used sedative-hypnotic agent for the induction and maintenance of general anesthesia. However, adverse events such as hypotension, and bradycardia are associated with propofol sedation. Ciprofol is a novel anesthetic/sedative agent similar to propofol, with an equivalent efficacy ratio to propofol of 1/4 to 1/5. Ciprofol has properties of fast onset of action, rapid recovery, reduced injection pain and stable cardiorespiratory function, making it a promising alternative to propofol. The aim of this study is to explore the safety and efficacy of ciprofol when used for general anesthesia in patients undergoing transcatheter aortic valve replacement compared to propofol.

Timeline

Start
2023-06-29
Primary completion
2024-07-08
Completion
2024-07-08

Drugs

EvaluationDrugModalityDoseRoute
Subject Cipepofol Small molecule 0.8 mg/kg Intravenous
Subject Cipepofol Small molecule 2.4 mg/kg Intravenous
Comparator Propofol Small molecule 4 mg/kg Intravenous
Comparator Propofol Small molecule 6 mg/kg Intravenous

Indications