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Neuroprotective anesthesia targets protocol aims to reduce silent brain infarction and perioperative neurocognitive disordersNew trial plans to protect brain health during heart surgery

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Key Takeaway
Note: This is a protocol; no results are available yet regarding the efficacy of neuroprotective anesthesia targets.

The study is a multicentre randomized controlled trial designed to evaluate the impact of neuroprotective anesthesia targets on patients undergoing elective cardiac surgery with cardiopulmonary bypass. The planned sample size is 912 participants.

The intervention group will receive care targeting specific parameters: mean arterial pressure of 65-90 mmHg, bispectral index of 40-60, bilateral regional cerebral oxygen saturation greater than or equal to 60%, and arterial inflow temperature below 37 degrees C with a rewarming rate less than 0.5 degrees C per minute after exceeding 30 degrees C during cardiopulmonary bypass. The comparator group will receive routine care.

The primary outcome is the 7-day incidence of new-onset silent brain infarction (SBI). Secondary outcomes include 30-day and 1-year incidences of perioperative neurocognitive disorders (PND), postoperative delirium, overt stroke, and transient ischaemic attack (TIA). Other secondary measures include composite major adverse events, length of stay in intensive care unit, hospital stay duration, and costs.

As this is a trial protocol, no results regarding safety, tolerability, or efficacy are currently available. The study aims to determine if specific anesthesia targets can reduce the incidence of SBI and PND in cardiac surgery patients.

How this fits prior evidence

How this fits prior evidence: This protocol addresses a gap in management strategies for perioperative neurocognitive disorders (PND) following major surgery. While previous coverage noted that extracellular vesicle signalling may participate in PND progression in older surgical patients, and parecoxib did not definitively lower neurocognitive disorder incidence in pancreaticoduodenectomy patients, this trial aims to evaluate specific physiological anesthesia targets to mitigate these outcomes in cardiac surgery.

Heart surgery is a major event, but it can sometimes lead to unexpected complications. One common issue is a silent brain infarction, which is a small area of tissue death in the brain that often goes unnoticed. Another concern is perioperative neurocognitive disorders, where patients experience confusion or cognitive struggles after their procedure.

A new study involving 912 patients will test if specific anesthesia targets can protect the brain. The team will monitor factors like blood pressure, oxygen levels in the brain, and body temperature during heart surgery. They want to see if these precise controls can reduce the risk of silent brain damage and long-term cognitive issues.

Because this is a study protocol, no results are available yet. The researchers are still in the planning and design phase. This trial will follow patients for up to one year to track their recovery and any potential complications after they leave the operating room.

What this means for you:
A new large trial aims to see if specific anesthesia targets can protect the brain during heart surgery.

Common questions

What is the goal of this new study?

The study aims to see if specific anesthesia targets, such as controlled blood pressure and oxygen levels, can protect the brain. The goal is to reduce the number of patients who experience silent brain infarctions or cognitive issues after undergoing elective heart surgery.

Who will participate in this trial?

The study plans to include 912 patients who are undergoing elective cardiac surgery that requires a cardiopulmonary bypass. This is a common procedure where a machine takes over the function of the heart and lungs during surgery.

Are there results available from this study yet?

No, results are not available yet because this is currently a study protocol. A protocol is a detailed plan for how a study will be conducted. The researchers are still in the design phase of the trial.

Study Details

Study typeRct
Sample sizen = 912
EvidenceLevel 2
Follow-up12.0 mo
PublishedJun 2026
View Original 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.
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