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

September 1, 2021 updated by: Haisco Pharmaceutical Group Co., Ltd.

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)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • Second Affiliated Hospital of Zhejiang University School of Medicine
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 85 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of time that BIS value is maintained between 40 and 60 (including boundary value)
Time Frame: Day 1
Day 1

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Haisco Pharmaceutical Group Co., Ltd.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

September 3, 2021

Primary Completion (Anticipated)

February 3, 2022

Study Completion (Anticipated)

February 4, 2022

Study Registration Dates

First Submitted

August 27, 2021

First Submitted That Met QC Criteria

September 1, 2021

First Posted (Actual)

September 5, 2021

Study Record Updates

Last Update Posted (Actual)

September 5, 2021

Last Update Submitted That Met QC Criteria

September 1, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HSK3486-IIT-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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