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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
24
Ciprofol infusion, starting with 0.8 \~ 1mg/kg/h until BIS value below 60 (including 60), and then 0.2 \~ 0.6mg/kg/h until the end of the operation, ciprofol infusion was adjusted to keep the BIS value between 40-60.
Propofol infusion, starting with 4 \~ 5mg/kg/h until BIS value below 60 (including 60), and then 1 \~ 3mg/kg/h until the end of the operation, propofol infusion was adjusted to keep the BIS value between 40-60.
Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
Time frame: Day 1
Time from the start of drug infusion to the first BIS reduction to 60
Time frame: Day 1
Time from the end of drug infusion to the recovery of BIS to 90
Time frame: Day 1
Percentage of subjects received rescue treatment
Time frame: Day 1
Incidence of hypotension
Time frame: Day 1
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