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

NCT ID: NCT05035069

Last Updated: 2021-09-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-03
• Study Completion Date: 2022-02-04

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.

Conditions

Anesthesia, General

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ciprofol

Group Type: EXPERIMENTAL

Ciprofol

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

Propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haisco Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Min Yan, M.D.

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital of Zhejiang University School of Medicine

Locations

Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Countries

China

Central Contacts

Fangqiong Li

Role: CONTACT

lifangq@haisco.com

+86 02867258840

Facility Contacts

Min Yan, M.D.

Role: primary

zryanmin@zju.edu.cn

Other Identifiers

HSK3486-IIT-02

Identifier Type: -

Identifier Source: org_study_id