Aortic Stenosis
Conditions
Interventions
Control group:Anesthesia induction was performed with intravenous injection of propofol at a dose of 1.5 mg/kg, and anesthesia maintenance was achieved with continuous intravenous infusion of propofol
Experimental group:Anesthesia induction was conducted with intravenous injection of remimazolam at a dose of 0.3 mg/kg, and anesthesia maintenance was maintained with continuous intravenous infusion o
Sponsors
General Hospital of Northern Theater Command
Eligibility
Sex/Gender
All
Age
65 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1.Patients undergoing elective transcatheter aortic valve replacement (transfemoral approach) under general anesthesia; 2.Diagnosed with severe symptomatic aortic stenosis (echocardiographic criteria: aortic valve area = 40 mmHg); 3.Age 65-85 years; 4.American Society of Anesthesiologists (ASA) physical status classification III-IV; 5.Preoperative hemodynamic stability (preoperative systolic blood pressure >= 90 mmHg, no need for intravenous inotropic agents for maintenance, heart rate >= 60 beats/min and = 10 breaths/min and = 95% on room air; 7.Patients or their guardians fully understand the study protocol and purpose and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Long-term use of benzodiazepines; 2. History of cognitive impairment or neuropsychiatric diseases, inability to cooperate with intraoperative sedation and anesthesia; 3. Uncontrolled severe arrhythmia; 4. Cardiogenic shock or requirement for mechanical circulatory support (e.g., ECMO, IABP); 5. Hepatic or renal insufficiency; 6. Chronic respiratory diseases (e.g., COPD, asthma, interstitial lung disease), acute respiratory infections (e.g., pneumonia, bronchitis), sleep-disordered breathing (e.g., OSA); 7. Allergy to drugs involved in the study; 8. Need for inotropic agents or mechanical ventilation; 9. Participation in any drug clinical trial within 1 month.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of hypotension after general anesthesia induction; | — |
Secondary
| Measure | Time frame |
|---|---|
| Anesthesia induction time;Success rate of sedation during anesthesia induction;Mean Arterial Pressure;Heart Rate;Respiratory Rate;Pulse Oxygen Saturation;Anesthesia recovery time;Intraoperative dosage of norepinephrine;Dosage of rescue sedative drugs;Number of respiratory depression episodes;Alanine Aminotransferase;Aspartate Aminotransferase;Serum Creatinine;Serum Urea;Creatine Kinase-MB Isoenzyme;N-terminal Pro-Brain Natriuretic Peptide;White Blood Cell;Neutrophil-to-Lymphocyte Ratio;Length of stay in cardiac intensive care unit;Total length of hospital stay;Intraoperative bradycardia;Intraoperative body movement;Injection pain during induction;Postoperative hypothermia;Postoperative nausea and vomiting;Postoperative delirium;Postoperative shivering; | — |
Countries
China
Contacts
Public ContactSun Yingjie
General Hospital of Northern Theater Command
Outcome results
None listed