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Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement

Primary Purpose

Hemodynamics, Transcatheter Aortic Valve Replacement, General Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ciprofol
propofol
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hemodynamics focused on measuring ciprofol, transcatheter aortic valve replacement, general anesthesia

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: patients planned for transfemoral transcatheter aortic valve replacement expected duration of surgery ≥ 1 and ≤ 3h patients undergoing general anesthesia no gender limit,age≥60 years,≤85 years BMI ≥18 and ≤30kg/m2 ASA physical status 3~4 be able to understand the procedures and methods of the trial and voluntarily sign the informed consent form Exclusion Criteria: predicted presence of difficult airway or previous history of difficult airway allergic to eggs, soy products, propofol, and opioids and their antidotes patients with shock or hypotension that is difficult to correct with vasopressor patients with mental, nervous system diseases, long-term use of sedatives or antidepressants HB < 10.0 g/dL (100 g/L) patients with previous long-term use of sedative and analgesic drugs patients with severe heart,lung,liver and kidney disease not suitable for participation in this study as assessed by the investigator

Sites / Locations

  • The Second Affiliated Hospital of Zhejiang University anesthesiology departmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group ciprofol

group propofol

Arm Description

Patients receive ciprofol for general anesthesia

Patients receive propofol for general anesthesia

Outcomes

Primary Outcome Measures

primary endpoint was the area under the curve below baseline MAP (MAP-time integral) during the 15 min after induction
the area under the baseline MAP over the first 15 min after induction, called the MAP-time integral

Secondary Outcome Measures

Incidence of hypotension
Hemodynamic variable
Incidence of bradycardia
Hemodynamic variable
dose of vasopressor used within 15 minutes after induction of anesthesia and vasopressor drugs used during surgery
Hemodynamic variable
Incidence of injection pain
injection pain
Incidence of postoperative nausea and vomiting
drug reaction
Quality of life and disease recovery (QoR-15) score on postoperative day 1
postoperative evaluation
changes of IL-6 before and one first day after surgery
inflammatory factor level
changes of CK-MB and cTnT before and one first day after surgery
myocardial enzyme level

Full Information

First Posted
May 15, 2023
Last Updated
July 6, 2023
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT05881291
Brief Title
Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement
Official Title
Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 29, 2023 (Actual)
Primary Completion Date
May 25, 2024 (Anticipated)
Study Completion Date
June 25, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Aortic valve stenosis is the most common debilitating valvular heart lesion in old patients. Transcatheter aortic valve replacement (TAVR) is an emergent technique for high-risk patients with aortic stenosis. In recent times, treatment has expanded to also include low- and intermediate-risk individuals. General anesthesia offers many advantages, mainly regarding the possibility of an early diagnosis and treatment of possible complications through the use of transesophageal echocardiography. Propofol is the most used sedative-hypnotic agent for the induction and maintenance of general anesthesia. However, adverse events such as hypotension, and bradycardia are associated with propofol sedation. Ciprofol is a novel anesthetic/sedative agent similar to propofol, with an equivalent efficacy ratio to propofol of 1/4 to 1/5. Ciprofol has properties of fast onset of action, rapid recovery, reduced injection pain and stable cardiorespiratory function, making it a promising alternative to propofol. The aim of this study is to explore the safety and efficacy of ciprofol when used for general anesthesia in patients undergoing transcatheter aortic valve replacement compared to propofol.
Detailed Description
After assessing patient eligibility, they were randomly assigned to two equally sized groups.Patients in this study were fasted for a minimum of 8 h without premedication. Following arrival in the operating room, patients were monitored with electrocardiography, respiratory rate, pulse oximetry, bispectral index (BIS), cerebral oxygen saturation,and continuous invasive arterial blood pressure. Induction of anesthesia: group ciprofol received an IV injection of ciprofol at a dose of 0.2-0.4 mg/kg, and administration time of 30 s; group propofol received an IV injection of propofol at a dose of 1.0-2.0 mg/kg, and administration time of 30 s. When the eyelash reflex disappeared and the BIS value was ≤60 administration was stopped, followed by an IV injection of alfentanil 30 μg/kg and rocuronium 0.6 mg/kg. Endotracheal intubation was performed when alfentanil and rocuronium had fully worked, and the BIS value was <50. A ventilator was then connected for mechanical ventilation using the following parameters: VT 6-8 ml/kg, RR 12-20 times/min, the inspiratory-to-expiratory ratio of 1:2, oxygen flowed 2 L/min, and maintaining PETCO2 at 35-45 mmHg (1 mmHg=0.133 kPa). Maintenance of anesthesia: group ciprofol received an IV infusion of ciprofol 0.8-2.4 mg·kg-1·h-1; group propofol received an IV infusion of propofol 4-6 mg·kg-1·h-1 .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hemodynamics, Transcatheter Aortic Valve Replacement, General Anesthesia, Post-induction Hypotension
Keywords
ciprofol, transcatheter aortic valve replacement, general anesthesia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
124 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
group ciprofol
Arm Type
Experimental
Arm Description
Patients receive ciprofol for general anesthesia
Arm Title
group propofol
Arm Type
Active Comparator
Arm Description
Patients receive propofol for general anesthesia
Intervention Type
Drug
Intervention Name(s)
ciprofol
Other Intervention Name(s)
alfentanil
Intervention Description
induction of anesthesia:group ciprofol received an IV injection of ciprofol at a dose of 0.2-0.4 mg/kg, and administration time of 30 s.When the eyelash reflex disappeared and the BIS value was ≤60 administration was stopped, followed by an IV injection of alfentanil 30 μg/kg and rocuronium 0.6 mg/kg. Maintenance of anesthesia: group ciprofol received an IV infusion of ciprofol 0.8-2.4 mg·kg-1·h-1.
Intervention Type
Drug
Intervention Name(s)
propofol
Other Intervention Name(s)
alfentanil
Intervention Description
induction of anesthesia:group propofol received an IV injection of propofol at a dose of 1.0-2.0 mg/kg, and administration time of 30 s. When the eyelash reflex disappeared and the BIS value was ≤60 administration was stopped, followed by an IV injection of alfentanil 30 μg/kg and rocuronium 0.6 mg/kg. Maintenance of anesthesia:group propofol received an IV infusion of propofol 4-6 mg·kg-1·h-1.
Primary Outcome Measure Information:
Title
primary endpoint was the area under the curve below baseline MAP (MAP-time integral) during the 15 min after induction
Description
the area under the baseline MAP over the first 15 min after induction, called the MAP-time integral
Time Frame
from the start of induction of anesthesia to 15 minutes after induction of anesthesia
Secondary Outcome Measure Information:
Title
Incidence of hypotension
Description
Hemodynamic variable
Time Frame
within 15 minutes after induction of anesthesia
Title
Incidence of bradycardia
Description
Hemodynamic variable
Time Frame
within 15 minutes after induction of anesthesia
Title
dose of vasopressor used within 15 minutes after induction of anesthesia and vasopressor drugs used during surgery
Description
Hemodynamic variable
Time Frame
during the surgery
Title
Incidence of injection pain
Description
injection pain
Time Frame
during the induction of anesthesia procedure
Title
Incidence of postoperative nausea and vomiting
Description
drug reaction
Time Frame
1 day (during anesthesia awakening)
Title
Quality of life and disease recovery (QoR-15) score on postoperative day 1
Description
postoperative evaluation
Time Frame
1 day after surgery
Title
changes of IL-6 before and one first day after surgery
Description
inflammatory factor level
Time Frame
immediately before surgery and one first day after surgery
Title
changes of CK-MB and cTnT before and one first day after surgery
Description
myocardial enzyme level
Time Frame
immediately before surgery and one first day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: patients planned for transfemoral transcatheter aortic valve replacement expected duration of surgery ≥ 1 and ≤ 3h patients undergoing general anesthesia no gender limit,age≥60 years,≤85 years BMI ≥18 and ≤30kg/m2 ASA physical status 3~4 be able to understand the procedures and methods of the trial and voluntarily sign the informed consent form Exclusion Criteria: predicted presence of difficult airway or previous history of difficult airway allergic to eggs, soy products, propofol, and opioids and their antidotes patients with shock or hypotension that is difficult to correct with vasopressor patients with mental, nervous system diseases, long-term use of sedatives or antidepressants HB < 10.0 g/dL (100 g/L) patients with previous long-term use of sedative and analgesic drugs patients with severe heart,lung,liver and kidney disease not suitable for participation in this study as assessed by the investigator
Facility Information:
Facility Name
The Second Affiliated Hospital of Zhejiang University anesthesiology department
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor
Phone
15888210247
Email
zryanmin@zju.edu.cn
First Name & Middle Initial & Last Name & Degree
Min Yan, Doctor

12. IPD Sharing Statement

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Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement

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