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

NCT ID: NCT05881291

Last Updated: 2026-01-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 124 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-29
• Study Completion Date: 2024-07-08

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 .

Conditions

Hemodynamics; Transcatheter Aortic Valve Replacement; General Anesthesia; Post-induction Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

group ciprofol

Patients receive ciprofol for general anesthesia

Group Type: EXPERIMENTAL

ciprofol

Intervention Type: DRUG

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.

group propofol

Patients receive propofol for general anesthesia

Group Type: ACTIVE_COMPARATOR

propofol

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

alfentanil; alfentanil

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

• Minimum Eligible Age: 60 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, China

Countries

China

References

Ni T, Zhou X, Wu S, Lv T, Hu Y, Gao Q, Luo G, Xie C, Zou J, Chen Y, Zhao L, Xiao J, Tao X, Yi Y, Xu Z, Wang T, Zhou J, Yao Y, Yan M. Hemodynamic Impact of Cipepofol vs Propofol During Anesthesia Induction in Patients With Severe Aortic Stenosis: A Randomized Clinical Trial. JAMA Surg. 2025 Jul 1;160(7):763-770. doi: 10.1001/jamasurg.2025.1299.

Reference Type: DERIVED

PMID: 40397427 (View on PubMed)

Other Identifiers

2023-0135

Identifier Type: -

Identifier Source: org_study_id