Effect of Personalized Blood Pressure Management on Postoperative Complications and Mortality in High-risk Patients Undergoing Major Non-cardiac Surgery: a Randomized Controlled Trial
High-risk populations, particularly elderly individuals and patients with cardiovascular comorbidities, exhibit markedly elevated incidences of postoperative myocardial injury (MINS), acute kidney injury (AKI), and mortality. Intraoperative hypotension (IOH), a pervasive clinical phenomenon affecting 40%-90% of surgical cases, Substantial observational evidence links IOH severity/duration to ischemic organ injuries (MINS, AKI) and long-term morbidity.Nevertheless, inherent limitations of observational designs-particularly residual confounding-preclude definitive causal inferences. Notably, randomized controlled trials (RCTs) investigating goal-directed hemodynamic interventions demonstrate inconsistent clinical benefits, underscoring the imperative to clarify causal mechanisms between IOH and organ injury. This causal ambiguity arises from two unresolved scientific questions: (1) Threshold personalization deficit; (2) Therapeutic strategy limitations. In light of current evidence, perioperative hypotension management demands personalized strategies, the investigators propose a multicenter randomized controlled trial (RCT) that aims to clarify the clinical benefits of individualized blood pressure management.
• Aged 65-90 yr;
• Scheduled to undergo elective non-cardiac major surgery under general anesthesia (with an estimated surgery duration of ≥ 2 hours and an anticipated postoperative hospital stay of ≥ 2 days);
• Patients with high cardiovascular risk, meeting at least one of the following conditions:
‣ History of stroke;
⁃ History of coronary artery disease;
⁃ History of congestive heart failure;
⁃ History of peripheral arterial disease;
⁃ Preoperative brain natriuretic peptide (BNP) ≥ 92 mg/L or N-terminal pro-brain natriuretic peptide (NT-proBNP) ≥ 300 ng/L;
⁃ Preoperative cardiac troponin (cTn) or high-sensitivity cardiac troponin (hs-cTn) \> upper reference limit;
⁃ Hypertension requiring medication treatment;
⁃ Diabetes requiring medication treatment;
⁃ History of chronic kidney disease;
‣ Continuous smoking for 2 years or more, with interruptions of less than one month before the current hospital admission;
‣ Hypercholesterolemia;
‣ History of transient ischemic attack.