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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05881291
Enrollment
124
Registered
2023-05-31
Start date
2023-06-29
Completion date
2024-07-08
Last updated
2026-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

ciprofol, transcatheter aortic valve replacement, general anesthesia

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 .

Interventions

DRUGciprofol

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.

DRUGpropofol

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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
Incidence of bradycardiawithin 15 minutes after induction of anesthesiaHemodynamic variable
dose of vasopressor used within 15 minutes after induction of anesthesia and vasopressor drugs used during surgeryduring the surgeryHemodynamic variable
Incidence of injection painduring the induction of anesthesia procedureinjection pain
Incidence of postoperative nausea and vomiting1 day (during anesthesia awakening)drug reaction
Incidence of hypotensionwithin 15 minutes after induction of anesthesiaHemodynamic variable
changes of IL-6 before and one first day after surgeryimmediately before surgery and one first day after surgeryinflammatory factor level
changes of CK-MB and cTnT before and one first day after surgeryimmediately before surgery and one first day after surgerymyocardial enzyme level
Composite Clinical Endpoint at 1 Year (Extended Follow-up Analysis)1 year post-procedureThe 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.
Quality of life and disease recovery (QoR-15) score on postoperative day 11 day after surgerypostoperative evaluation

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026