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HemodynamicsPhase 4NCT05881291

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

A Phase 4 study testing ciprofol and propofol in people with Hemodynamics and Transcatheter Aortic Valve Replacement, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 60 to 85 years
What is being tested?
ciprofol and propofol
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteChina
Study dates
29 Jun 2023to 8 Jul 2024
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 60 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

China1 site

  • The Second Affiliated Hospital of Zhejiang University anesthesiology department

    Hangzhou, Zhejiang, 310000

Other trials in China

About this study

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.

Read the 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 .

Being tested
ciprofol, propofol
Keywords
ciprofol, transcatheter aortic valve replacement, general anesthesia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ciprofolDrug

    Also called alfentanil

    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.

  • propofolDrug

    Also called alfentanil

    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.

Study groups in NCT05881291
Study groupRoleWhat they receive
group ciprofolExperimentalPatients receive ciprofol for general anesthesia
Receives: Drug: ciprofol
group propofolActive comparatorPatients receive propofol for general anesthesia
Receives: Drug: propofol

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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

    Measured: from the start of induction of anesthesia to 15 minutes after induction of anesthesia

Secondary outcomes (9)

  1. Incidence of hypotension

    Hemodynamic variable

    Measured: within 15 minutes after induction of anesthesia

  2. Incidence of bradycardia

    Hemodynamic variable

    Measured: within 15 minutes after induction of anesthesia

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

    Hemodynamic variable

    Measured: during the surgery

  4. Incidence of injection pain

    injection pain

    Measured: during the induction of anesthesia procedure

  5. Incidence of postoperative nausea and vomiting

    drug reaction

    Measured: 1 day (during anesthesia awakening)

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

    postoperative evaluation

    Measured: 1 day after surgery

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

    inflammatory factor level

    Measured: immediately before surgery and one first day after surgery

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

    myocardial enzyme level

    Measured: immediately before surgery and one first day after surgery

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

    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.

    Measured: 1 year post-procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 May 2023
  2. Study start29 Jun 2023
  3. Primary completion8 Jul 2024
  4. Study completion8 Jul 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05881291
Sponsor's protocol ID
2023-0135
Status last verified
Jul 2024
First submitted
15 May 2023
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 40397427

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing ciprofol and propofol in people with Hemodynamics and Transcatheter Aortic Valve Replacement, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05881291, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jan 2026.

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