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

Sponsor

Haisco Pharmaceutical Group Co., Ltd. (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT05035069

Collaborator

(none)

Enrollment

Location

Arms

5.1

Anticipated Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Anesthesia, General	Drug: Ciprofol Drug: Propofol	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

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)

Anticipated Study Start Date :

Sep 3, 2021

Anticipated Primary Completion Date :

Feb 3, 2022

Anticipated Study Completion Date :

Feb 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Ciprofol	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.
Active Comparator: Propofol	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.

Arm

Intervention/Treatment

Experimental: Ciprofol

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.

Active Comparator: Propofol

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.

Outcome Measures

Primary Outcome Measures

Percentage of time that BIS value is maintained between 40 and 60 (including boundary value) [Day 1]

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

65 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang	China	310009

Sponsors and Collaborators

Haisco Pharmaceutical Group Co., Ltd.

Investigators

Principal Investigator: Min Yan, M.D., Second Affiliated Hospital of Zhejiang University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Haisco Pharmaceutical Group Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05035069

Other Study ID Numbers:

HSK3486-IIT-02

First Posted:

Sep 5, 2021

Last Update Posted:

Sep 5, 2021

Last Verified:

Aug 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Propofol

Study Results

No Results Posted as of Sep 5, 2021