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

• Status: Not yet recruiting
• Trial end date: 2024-06-25
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Treatments: Alfentanil; Propofol

Criteria

Inclusion Criteria:

• patients planned for transfemoral transcatheter aortic valve replacement

• expected duration of surgery ≥ 1 and ≤ 3h

• patients undergoing general anesthesia

• no gender limit，age≥60 years，≤85 years

• BMI ≥18 and ≤30kg/m2

• ASA physical status 3~4

• be able to understand the procedures and methods of the trial and voluntarily sign the informed consent form

Exclusion Criteria:

• predicted presence of difficult airway or previous history of difficult airway

• allergic to eggs, soy products, propofol, and opioids and their antidotes

• patients with shock or hypotension that is difficult to correct with vasopressor

• patients with mental, nervous system diseases, long-term use of sedatives or antidepressants

• HB < 10.0 g/dL (100 g/L)

• patients with previous long-term use of sedative and analgesic drugs

• patients with severe heart，lung，liver and kidney disease

• not suitable for participation in this study as assessed by the investigator