the purpose of the study is to investigate whether a combined anesthetic targets bundle, known as the NeuroFirst strategy, focused on neurological protection, can reduce the incidence of silent brain infarction (SBI) and perioperative neurocognitive disorders (PND) in patients undergoing cardiac surgery. Additionally, the trial will assess the safety of this strategy.
The NeuroFirst target bundle incorporates multiple parameters, including mean arterial pressure (MAP), bispectral index (BIS), regional cerebral oxygen saturation (rSO2), and arterial inflow temperature during cardiopulmonary bypass.
The primary question this study seeks to answer is: Does the NeuroFirst strategy reduce the incidence of SBI and PND in cardiac surgery?
To address this, researchers will compare the NeuroFirst strategy with routine institutional practices based on published guidelines. Participants will be randomly assigned to either the NeuroFirst group or the routine care group. All participants will undergo magnetic resonance imaging (MRI), be assessed using the Confusion Assessment Method (CAM) and the Montreal Cognitive Assessment (MoCA), and be followed for up to one year postoperatively.
Male or female adult patients aged 60 years or older
Receiving elective cardiovascular surgery with cardiopulmonary bypass
Written Informed consent provided
Contraindication to MRI scanning
Not suitable for receiving interventions to achieve NeuroFirst target bundle
Unable to receive neuro-cognitive evaluation due to language, vision, or hearing impairments
Breastfeeding or pregnancy
Parallel
Managements for NeuroFirst target bundle
Other interventionIn the intervention group, patient management aims to achieve the NeuroFirst target bundle, including 1) mean arterial pressure (MAP) 65-90 mmHg, 2) bispectral index (BIS) 40-60, 3) regional cerebral oxygen saturation (rSO2)≥ 60% , and 4) arterial inflow temperature \<37 ℃ and rewarming rate \< 0.5 ℃/min after exceeding 30℃ during CPB. To achieve this target bundle, pharmacologic agents, fluid resuscitation, blood transfusion, and other therapeutic modalities will be utilized. These interventions are guided by comprehensive intraoperative monitoring, including conventional hemodynamic monitoring, invasive or non-invasive cardiac output and vascular resistance assessments.
Managements for institutional routine
Other interventionMAP, BIS, cerebral rSO2 and arterial inflow temperature during CPB rewarming, will be managed according to institutional routine in accordance with published guidelines.
the 7-day incidence of new-onset silent brain infarction (SBI)
New-onset silent brain infarction refers to newly developed cerebral infarctions detected on MRI, compared with the preoperative MRI, in the absence of any corresponding clinical symptoms of cerebral infarction.
Key Secondary Outcome: the 30-day incidence of perioperative neurocognitive disorders (PND)
The incidence of 30-day PND includes the incidence of postoperative delirium in hospital and perioperative neurocognitive disorders within 30 days after surgery
the 5-day incidence of postoperative delirium
the incedence of delirium evaluated by CAM/CAM-ICU
the 30-day incidence of new-onset overt stroke
Postoperative new-onset overt stroke was defined as any new ischemic or hemorrhagic cerebrovascular event after surgery with focal or global neurological (motor, sensory or cognitive) dysfunction lasting at least 24 h. And a broadened stroke definition also including neurological dysfunction of \<24 h duration with corresponding evidence of central nervous system hemorrhage or infarction (including pathological, imaging, or other objective evidence of cerebral, spinal cord or retinal focal ischemic injury in a defined vascular distribution).
the 1-year incidence of new-onset overt stroke
Postoperative new-onset overt stroke was defined as any new ischemic or hemorrhagic cerebrovascular event after surgery with focal or global neurological (motor, sensory or cognitive) dysfunction lasting at least 24 h. And a broadened stroke definition also including neurological dysfunction of \<24 h duration with corresponding evidence of central nervous system hemorrhage or infarction (including pathological, imaging, or other objective evidence of cerebral, spinal cord or retinal focal ischemic injury in a defined vascular distribution).
Length of stay (LOS) in intensive care unit (ICU)
Length of stay (LOS) in intensive care unit (ICU) postoperatively
Length of stay (LOS) in hospital
Length of stay (LOS) in hospital postoperatively
Hospitalization cost
Operative and postoperative hospitalization cost
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