Valvular heart disease
Conditions
Interventions
Ciprofol Group :Anesthesia induction and maintenance protocols shall be implemented using ciprofol.
Propofol Group :Anesthesia induction and maintenance protocols shall be implemented using propofol.
Sponsors
Meishan People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years, regardless of gender; 2. Scheduled to undergo cardiac valve surgery under cardiopulmonary bypass; 3. ASA classification of Grade II or above, and NYHA functional class II–IV; 4. Body Mass Index (BMI) between 18 kg/m² and 30 kg/m²; 5. Fully understand and voluntarily agree to participate in this study, and provide written informed consent signed by the patient with full civil capacity.
Exclusion criteria
Exclusion criteria: (1) Hypovolemia, shock, preoperative infusion of vasoactive drugs, or comatose state; (2) Plans requiring other anesthesia methods in addition to general anesthesia, such as epidural or subarachnoid anesthesia; (3) Acute heart failure, unstable angina; history of myocardial infarction within 6 months prior to screening; (4) Infectious cardiac diseases such as myocarditis or endocarditis; sepsis; (5) Patients with severe arrhythmias, including but not limited to resting ECG heart rate =450 ms, female >=470 ms; (6) Hypertensive patients whose blood pressure is not satisfactorily controlled with antihypertensive medication (seated systolic blood pressure >=160 mmHg and/or seated diastolic blood pressure >=100 mmHg during screening); (7) Seated systolic blood pressure =1.5xULN, APTT >=1.5xULN); (9) Anemia or thrombocytopenia (Hb =2.5xULN, TBIL >=1.5xULN); (11) Abnormal renal function (BUN >=1.5xULN, serum creatinine >=1.0xULN); (12) Diabetic patients with unsatisfactory blood glucose control (blood glucose >=11.1 mmol/L during screening); (13) History of drug abuse and/or alcohol abuse within 2 years prior to screening, with alcohol abuse defined as an average daily intake exceeding 2 units of alcohol (1 unit = 360 ml beer, or 45 ml of 40% alcohol spirits, or 150 ml wine); (14) Individuals with mental health disorders (such as schizophrenia, mania, bipolar disorder, and mental confusion), a long-term history of taking psychiatric medications, and cognitive dysfunction; (15) Pregnant or lactating women; (16) Hypersensitivity or contraindication to benzodiazepines, opioids, ciprofol, propofol, muscle relaxants, or their components; (17) Patients judged to have difficult airway management (Modified Mallampati score of Class IV); (18) Participation in a drug clinical trial as a subject within the past 3 months; (19) Other conditions considered by the investigator as unsuitable for participation in this trial; (20) Patients with myasthenia gravis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Post-induction hypotension (PIH);Total dose of norepinephrine used; | — |
Secondary
| Measure | Time frame |
|---|---|
| Myocardial enzyme measurements;Postoperative recovery; | — |
Countries
China
Contacts
Public ContactXia Dingchao
Meishan People's Hospital
Outcome results
None listed