BMJ Open. 2026 Jun 19;16(6):e116246. doi: 10.1136/bmjopen-2026-116246.
ABSTRACT
INTRODUCTION: The incidence of silent brain infarction (SBI) and perioperative neurocognitive disorders (PND) is higher in cardiac surgery. However, standard preventive strategies remain unknown due to limited evidence.
METHODS AND ANALYSIS: This multicentre, prospective, randomised controlled clinical trial with a 1-year follow-up includes patients undergoing elective cardiac surgery with cardiopulmonary bypass (CPB). 912 participants are randomly assigned 1:1 into either the intervention group with neuroprotective anaesthesia targets (mean arterial pressure 65-90 mm Hg, bispectral index 40-60, bilateral regional cerebral oxygen saturation ≥60%, arterial inflow temperature <37℃ and rewarming rate <0.5℃/min after exceeding 30℃ during CPB) or the control group maintained by anaesthetists according to routine care. The primary outcome is the 7-day incidence of new-onset SBI. The key secondary outcome is the 30-day incidence of PND. The secondary outcomes include the 5-day incidence of postoperative delirium, the 30-day incidence of new-onset overt stroke, the 1-year incidence of new-onset overt stroke, the 30-day incidence of transient ischaemic attack (TIA), the 1-year incidence of TIA, the 1-year incidence of PND, the 30-day and 1-year composite incidence of major adverse events (renal insufficiency, myocardial infarction, pulmonary embolism, seizure, all-cause mortality), length of stay (LOS) in intensive care unit, LOS in hospital and hospitalisation cost.
ETHICS AND DISSEMINATION: The trial was approved by the Institutional Review Board/Independent Ethics Committee of Fuwai Hospital (Approval No. 2024-2445) and all participating centres. We will disseminate the trial findings in peer-reviewed journals and present the results at national or international conferences.
TRIAL REGISTRATION NUMBER: NCT07048002.
PMID:42320960 | DOI:10.1136/bmjopen-2026-116246