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NCT06225453
Individualized Versus Conventional Perioperative Blood Pressure Management
Conditions: Major Non-cardiac Surgery
Sex: All
Ages: 45 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 1896
Sponsor: Seoul National University Hospital
Location: Seoul National University Bundang Hospital Seongnam
Summary
Study objective: To compare the effect of different perioperative blood pressure management strategies on major postoperative adverse outcomes / Study design: a multicenter, randomized controlled trial / Participants: 1896 patients undergoing major non-cardiac surgery / Methods: Patients are randomized into two groups, the individualized strategy (maintaining perioperative mean arterial pressure and systolic blood pressure more than -20% of their baseline values) or the conventional strategy (maintaining perioperative mean arterial pressure ≥65 mmHg and systolic blood pressure ≥90 mmHg in all patients). Then, the frequency of major postoperative adverse outcomes occurring within 7 postoperative days or before discharge (whichever occurs first). / Primary outcome: a composite of all-cause death, stroke, myocardial infarction, new or worsening congestive heart failure, unplanned coronary revascularization, and acute kidney injury, occuring within 7 postoperative days or before discharge (whichever occurs first).
Eligibility Criteria
Inclusion Criteria:
* Patients aged ≥65 or,
* those aged ≥45 with a history of coronary artery disease, peripheral vascular disease, transient ischemic attack/stroke, or congestive heart failure,
* undergoing non-cardiac surgery under general anesthesia with an anticipated duration of ≥2 hours.
Exclusion Criteria:
* Emergency surgery
* Organ transplantation surgery
* Brain/carotid artery surgery
* American Society of Anesthesiologists physical status 5 or 6
* Pregnancy
* Uncontrolled preoperative hypertension (systolic blood pressure ≥180 mmHg or diastolic blood pressure ≥110 mmHg)
* Estimated glomerular filtration rate \
Source: ClinicalTrials.gov (NCT06225453). StuddyBuddy aggregates publicly available trial information.