General Anesthesia Clinical Trial
Official title:
Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement
NCT number | NCT05881291 |
Other study ID # | 2023-0135 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | June 29, 2023 |
Est. completion date | June 25, 2024 |
Verified date | April 2023 |
Source | Second Affiliated Hospital, School of Medicine, Zhejiang University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | June 25, 2024 |
Est. primary completion date | May 25, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
China | The Second Affiliated Hospital of Zhejiang University anesthesiology department | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | from the start of induction of anesthesia to 15 minutes after induction of anesthesia | |
Secondary | Incidence of hypotension | Hemodynamic variable | within 15 minutes after induction of anesthesia | |
Secondary | Incidence of bradycardia | Hemodynamic variable | within 15 minutes after induction of anesthesia | |
Secondary | dose of vasopressor used within 15 minutes after induction of anesthesia and vasopressor drugs used during surgery | Hemodynamic variable | during the surgery | |
Secondary | Incidence of injection pain | injection pain | during the induction of anesthesia procedure | |
Secondary | Incidence of postoperative nausea and vomiting | drug reaction | 1 day (during anesthesia awakening) | |
Secondary | Quality of life and disease recovery (QoR-15) score on postoperative day 1 | postoperative evaluation | 1 day after surgery | |
Secondary | changes of IL-6 before and one first day after surgery | inflammatory factor level | immediately before surgery and one first day after surgery | |
Secondary | changes of CK-MB and cTnT before and one first day after surgery | myocardial enzyme level | immediately before surgery and one first day after surgery |
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