Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aort… (NCT05881291) | Clinical Trial Compass
CompletedPhase 4
Efficacy and Safety of Ciprofol for General Anaesthesia in Patients Undergoing Transcatheter Aortic Valve Replacement
China124 participantsStarted 2023-06-29
Plain-language 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.
Who can participate
Age range
60 Years – 85 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
primary endpoint was the area under the curve below baseline MAP (MAP-time integral) during the 15 min after induction
Timeframe: from the start of induction of anesthesia to 15 minutes after induction of anesthesia
Trial details
NCT IDNCT05881291
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University