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

Haisco Pharmaceutical Group

Status and phase

Unknown

Phase 4

Conditions

Anesthesia, General

Treatments

Drug: Ciprofol

Drug: Propofol

Study type

Interventional

Funder types

Industry

Identifiers

NCT05035069

HSK3486-IIT-02

Details and patient eligibility

About

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).

Full description

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.

Enrollment

24 estimated patients

Sex

All

Ages

65 to 85 years old

Volunteers

No Healthy Volunteers

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.