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

Phase 4

• Conditions: Anesthesia, General
• Interventions: Drug: Propofol; Drug: Ciprofol

• Registration Number: NCT05035069
• Lead Sponsor: Haisco Pharmaceutical Group Co., Ltd.

Brief 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).

Detailed 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.

Study Timeline

• Status Verified: 2021-08
• Study First Submitted: 2021-08-27
• Study First Submitted QC: 2021-09-01
• Last Update Submitted: 2021-09-01
• Study Start: 2021-09-03
• Study First Posted: 2021-09-05
• Last Update Posted: 2021-09-05
• Primary Completion: 2022-02-03
• Study Completion: 2022-02-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	-
Ciprofol	Ciprofol	-

Primary Outcome Measures

Name	Time	Method
Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)	Day 1

Secondary Outcome Measures

Name	Time	Method
Time from the start of drug infusion to the first BIS reduction to 60	Day 1
Percentage of subjects received rescue treatment	Day 1
Time from the end of drug infusion to the recovery of BIS to 90	Day 1
Incidence of hypotension	Day 1

Trial Locations

Locations (1)

Second Affiliated Hospital of Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China