Safety and Effectiveness of Ciprofol in Cardiac Surgery Anesthesia
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Le Yu
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Mean arterial pressure
Overview
Brief Summary
Ciprofol, a novel intravenous general anesthetic with a chemical structure akin to propofol, boasts significantly enhanced potency. It offers a rapid onset, reduced incidence of injection pain, and minor impact on the cardiovascular system. However, clinical research regarding ciprofol's use for anesthesia induction in cardiac surgery remains limited. The investigators want to assesse the safety and effectiveness of ciprofol in cardiac surgery anesthesia
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 55 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Elective surgery patients
- •Aged 55 to 75
- •New York Heart Association class II or III cardiac functions
- •Median sternotomy approach for coronary artery bypass grafting or heart valve replacement procedures.
Exclusion Criteria
- •With a history of benzodiazepine allergy
- •Significant liver or kidney insufficiency
- •Coagulation dysfunction
- •Neurological or psychiatric disorders
- •Undergone major surgery within the past three months.
Arms & Interventions
ciprofol
Intervention: ciprofol injection (Drug)
propofol
Intervention: Propofol injection (Drug)
Outcomes
Primary Outcomes
Mean arterial pressure
Time Frame: 5 minutes after tracheal intubation (T4)
an average blood pressure in an individual during a single cardiac cycle
Heart beats
Time Frame: 5 minutes after tracheal intubation (T4).
the number of times each minute that heart beats
Secondary Outcomes
- Oxygenation index(10 minutes after tracheal intubation (T5).)
- Injection pain(During procedure (When injecting the drug, ask the subject if the injection site is painful))
Investigators
Le Yu
Clinicians
Shanghai East Hospital of Tongji University