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

• Status: Not yet recruiting
• Trial end date: 2022-02-04
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.
• Treatments: Propofol

Criteria

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.