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

Anesthesia, General Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05035069
• Other study ID #: HSK3486-IIT-02
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: September 3, 2021
• Est. completion date: February 4, 2022

Study information

• Verified date: August 2021
• Source: Haisco Pharmaceutical Group Co., Ltd.
• Contact: Fangqiong Li
• Phone: +86 02867258840
• Email: lifangq[@]haisco.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 24
• Est. completion date: February 4, 2022
• Est. primary completion date: February 3, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years to 85 Years

Eligibility

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 ?~?

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.

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Haisco Pharmaceutical Group Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)		Day 1
Secondary	Time from the start of drug infusion to the first BIS reduction to 60		Day 1
Secondary	Time from the end of drug infusion to the recovery of BIS to 90		Day 1
Secondary	Percentage of subjects received rescue treatment		Day 1
Secondary	Incidence of hypotension		Day 1