Efficacy and Safety of Ciprofol Compared to Propofol for Nonintubated General Anesthesia in Patients Undergoing TAVR

A Randomized, Single-Blinded, Parallel Single-Center Clinical Study Exploring the Efficacy and Safety of Ciprofol and Propofol for Nonintubated General Anesthesia in Patient Undergoing Transcatheter Aortic Valve Replacement (TAVR)

The purpose of this study is to explore the efficacy and safety of ciprofol compared to propofol for non-intubated general anesthesia in patients undergoing transcatheter aortic valve replacement (TAVR).

This is a study in subjects undergoing transcatheter aortic valve replacement (TAVR). As designed, the study will include 1-day screening period, 1-day observation period, and 1-day safety follow-up. Participants will be randomly assigned to either experimental or control group with a 1:1 allocation, with 12 subjects in each group.

Inclusion Criteria:

• Patient scheduled for TAVR through femoral artery access
• 1h ≤ Expected duration of surgery ≤ 3h
• Planned for general anesthesia without intubation
• 18 ≤ BMI ≤ 30
• ASA category Ⅱ～Ⅳ

Exclusion Criteria:

• Contraindications to anesthesia/sedation or a history of adverse reaction to anesthesia/sedation
• Known allergies to eggs, soy products, opioids and their antidotes, propofol, etc; Contraindications of propofol, opioids and their antidotes
• Shock and hypotension difficult that is to be corrected by vasoactive drugs in the screening period
• Hemoglobin (HB) < 10.0 g / dl (100 g / L)
• Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.