Interventions for Silent Brain Infarction and Perioperative Neurocognitive Disorders in Cardiovascular Surgery (INSPIRE): study protocol for a multicentre randomised controlled trial.

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.