NCT05035069

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

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)

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Haisco Pharmaceutical Group Co., Ltd. · Industry
• Sex: All
• Age: 65 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Anesthesia, General

Interventions

Type	Name	Description
DRUG	Ciprofol	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.
DRUG	Propofol	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.

Timeline

• Start date: 2021-09-03
• Primary completion: 2022-02-03
• Completion: 2022-02-04
• First posted: 2021-09-05
• Last updated: 2021-09-05

Locations

1 site across 1 country: China