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

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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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)

Conditions
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Anesthesia, General

Intervention / Treatment
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* Drug: Ciprofol
* Drug: Propofol


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 65 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ciprofol<br> | Drug: Ciprofol<br>* 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.<br>|
| Active Comparator: Propofol<br> | Drug: Propofol<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of time that BIS value is maintained between 40 and 60 (including boundary value) |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from the start of drug infusion to the first BIS reduction to 60 |  | Day 1 | 
| Time from the end of drug infusion to the recovery of BIS to 90 |  | Day 1 | 
| Percentage of subjects received rescue treatment |  | Day 1 | 
| Incidence of hypotension |  | Day 1 |