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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05035069
Other study ID # HSK3486-IIT-02
Secondary ID
Status Not yet recruiting
Phase Phase 4
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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