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Completed

NCT Number: NCT05881291

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

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.

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Key information

Age range

60 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Second Affiliated Hospital of Zhejiang University anesthesiology department

Hangzhou, Zhejiang, 310000, China

About this study

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 .

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ciprofol

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.

Other names: alfentanil

Propofol

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.

Other names: alfentanil

Primary outcomes

  1. primary endpoint was the area under the curve below baseline MAP (MAP-time integral) during the 15 min after induction

    Time frame: 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 outcomes

  1. Incidence of hypotension

    Time frame: within 15 minutes after induction of anesthesia

    Hemodynamic variable

  2. Incidence of bradycardia

    Time frame: within 15 minutes after induction of anesthesia

    Hemodynamic variable

  3. dose of vasopressor used within 15 minutes after induction of anesthesia and vasopressor drugs used during surgery

    Time frame: during the surgery

    Hemodynamic variable

  4. Incidence of injection pain

    Time frame: during the induction of anesthesia procedure

    injection pain

  5. Incidence of postoperative nausea and vomiting

    Time frame: 1 day (during anesthesia awakening)

    drug reaction

  6. Quality of life and disease recovery (QoR-15) score on postoperative day 1

    Time frame: 1 day after surgery

    postoperative evaluation

  7. changes of IL-6 before and one first day after surgery

    Time frame: immediately before surgery and one first day after surgery

    inflammatory factor level

  8. changes of CK-MB and cTnT before and one first day after surgery

    Time frame: immediately before surgery and one first day after surgery

    myocardial enzyme level

  9. Composite Clinical Endpoint at 1 Year (Extended Follow-up Analysis)

    Time frame: 1 year post-procedure

    The composite endpoint is defined as the occurrence of all-cause mortality, stroke, acute kidney injury (AKI), myocardial infarction (MI), or new-onset atrial fibrillation (NOAF). This is a post-hoc extended analysis. While the original trial protocol focused on intraoperative hemodynamics, these long-term data were prospectively collected via the institutional TAVR registry. The analysis of these 1-year outcomes was authorized under a specific ethical approval (No. 2025-1849) obtained after the primary trial completion.

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
May 31, 2023
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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