Moderate-to-high risk patients undergoing non-cardiac major surgery with an indication for controlled hypotension
Conditions
Interventions
Control group:Intraoperative MAP target >=70 mmHg
Trial group :Controlled hypotension to a MAP target of 55-65 mmHg during high blood-loss portions of surgery.
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Consenting patients >=45 years old. 2. Elective major non-cardiac surgery with general anesthesia expected to last at least 2 hours. 3. Indications for controlled hypotension to reduce blood loss. 4. Expected to require at least two nights of hospitalization. 5. ASA physical status 2-4. 6. Expected to have intraoperative blood pressure monitoring with an arterial catheter. 7. Cared for by clinicians willing to follow this trial protocol. 8. Subject to at least one of the following risk factors: a. Hypertension requiring treatment b. History of peripheral arterial disease. c. History of coronary artery disease. d. History of stroke or transient ischemic attack. e. Serum creatinine >175 µmol/L (>2.0 mg/dl) within 6 months. f. Diabetes requiring medication or insulin. g. Current smoking or 15 pack-year history of smoking tobacco. h. Body mass index >=35 kg/m^2. i. Preoperative high-sensitive troponin T test (>0.014 ng/ml) or creatine kinase-MB (>4.87 ng/ml) above the upper limit of normal within 6 months. j. N-terminal B-type natriuretic protein (NT-ProBNP) >300 pg/ml within six months. k. Age >65 years.
Exclusion criteria
Exclusion criteria: 1. Preoperative intravenous vasoactive medications. 2. Severe coagulation disorders. 3. Systemic infectious disease. 4. Severe cardiovascular conditions requiring acute care: a. Unstable coronary artery disease or acute myocardial infarction within 6 months. b. Severe heart failure (e.g., NYHA Class III-IV). c. Significant arrhythmias or untreated severe valvular heart disease. 5. Severe renal impairment (eGFR< 30 mL/min/1.73 m²). 6. Dementia severe enough to impede informed consent. 7. Language, vision, or hearing impairments that may compromise cognitive assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite of major perfusion-related complications, including myocardial injury after non-cardiac surgery, stroke, non-fatal cardiac arrest, Stage 2-3 acute kidney injury, and death. ; | — |
Secondary
| Measure | Time frame |
|---|---|
| blood loss;Red cell transfusions;postoperative delirium; | — |
Countries
China
Contacts
Public ContactChanghong Miao
Zhongshan Hospital, Fudan University
Outcome results
None listed