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

Sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05881291

Collaborator

(none)

124

Enrollment

Location

Arms

Anticipated Duration (Months)

9.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamics Transcatheter Aortic Valve Replacement General Anesthesia Post-induction Hypotension	Drug: ciprofol Drug: propofol	N/A

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 .

Study Design

Study Type:

Interventional

Anticipated Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

May 25, 2023

Anticipated Primary Completion Date :

May 25, 2024

Anticipated Study Completion Date :

Jun 25, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: group ciprofol Patients receive ciprofol for general anesthesia	Drug: ciprofol 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. Other Names: alfentanil
Active Comparator: group propofol Patients receive propofol for general anesthesia	Drug: propofol 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. Other Names: alfentanil

Arm

Intervention/Treatment

Experimental: group ciprofol

Patients receive ciprofol for general anesthesia

Drug: ciprofol

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.

Other Names:

alfentanil

Active Comparator: group propofol

Patients receive propofol for general anesthesia

Drug: propofol

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.

Other Names:

alfentanil

Outcome Measures

Primary Outcome Measures

primary endpoint was the area under the curve below baseline MAP (MAP-time integral) during the 15 min after induction [from the start of induction of anesthesia to 15 minutes after induction of anesthesia]
the area under the baseline MAP over the first 15 min after induction, called the MAP-time integral

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

60 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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