High-risk patients for non-cardiac surgery
Conditions
Interventions
Trial group:Anesthesia induction with remazolam 0.2-0.5 mg/kg, maintenance of BIS between 45 and 60, maximum infusion rate of remazolam not exceeding 2 mg/kg/h
Control group:Anesthesia induction with propofol 1-2 mg/kg, maintenance of BIS between 45 and 60
Sponsors
The First Affiliated Hospital of Nanchang University
Eligibility
Sex/Gender
All
Age
60 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 60 years old; 2. Revised Cardiac Risk Index (RCRI) >= 3 points; The Revised Cardiac Risk Index (RCRI) is widely used to predict the risk of cardiac complications in patients undergoing non-cardiac surgery. This index includes six independent predictors: (1) high-risk surgery (such as intra-abdominal, intrathoracic, and suprainguinal vascular surgery); (2) ischemic heart disease; (3) congestive heart failure; (4) cerebrovascular disease; (5) preoperative insulin therapy; (6) serum creatinine > 176.8 µmol/L. Patients with three or more predictors are classified as high-risk groups; 3. Planned to undergo major non-cardiac surgery (expected operation duration >= 2 hours, postoperative hospital stay >= 3 days); 4. Voluntarily participate and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Known history of allergy to any drug used in this study protocol; 2. Severe liver or renal insufficiency (defined as Child-Pugh Class C, or currently receiving maintenance renal replacement therapy); 3. Severe cardiovascular diseases: such as persistent atrial fibrillation, acute myocardial infarction, etc.; 4. Preoperative history of neuropsychiatric diseases such as schizophrenia, epilepsy, Parkinson's disease, delirium, etc.; 5. Inability to cooperate with relevant assessments due to dementia, aphasia, severe hearing or language impairment, etc.; 6. Long-term history of sedative or antidepressant use, or history of psychoactive substance abuse and alcoholism; 7. Planned to undergo neurosurgical surgery; 8. Currently participating in other clinical trials or other situations deemed unsuitable for participation in the study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of severe postoperative complications requiring medical intervention within 30 days after surgery (Clavien-Dindo Grade >= 2). The occurrence of any one of the following systemic com; | — |
Secondary
| Measure | Time frame |
|---|---|
| Extubation Time;Length of Hospital Stay;Sleep Quality;Postoperative Recovery Quality;PACU Stay Time;Hemodynamic Stability Indicators During Anesthesia;Awakening Time;Medical Expenses During Hospitalization;Postoperative ICU Admission;Pain Intensity; | — |
Countries
China
Contacts
Public ContactWei Qingfeng
The First Affiliated Hospital of Nanchang University
Outcome results
None listed