The Second Affiliated Hospital of Zhejiang University anesthesiology department
Hangzhou, Zhejiang, 310000, China
NCT Number: NCT05881291
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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Notify Me60 year–85 year
All sexes
Interventional
Phase 4
Hangzhou, Zhejiang, 310000, China
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 .
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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
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
Time frame: within 15 minutes after induction of anesthesia
Hemodynamic variable
Time frame: within 15 minutes after induction of anesthesia
Hemodynamic variable
Time frame: during the surgery
Hemodynamic variable
Time frame: during the induction of anesthesia procedure
injection pain
Time frame: 1 day (during anesthesia awakening)
drug reaction
Time frame: 1 day after surgery
postoperative evaluation
Time frame: immediately before surgery and one first day after surgery
inflammatory factor level
Time frame: immediately before surgery and one first day after surgery
myocardial enzyme level
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.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
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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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