About this trial

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.

Eligibility criteria

Qualifiers

Male or female adult patients aged 60 years or older

Receiving elective cardiovascular surgery with cardiopulmonary bypass

Written Informed consent provided

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Managements for NeuroFirst target bundle
  • Managements for institutional routine

Treatment groups

912 Participants
are divided into 2 treatment groups

Locations

5
Beijing Chaoyang Hospital,Capital Medical University100020, BeijingBeijing Municipality, China
Beijing Tiantan Hospital, Capital Medical University100160, BeijingBeijing Municipality, China
State Key Laboratory of Cardiovascular Disease, Fuwai Hospital, National Center for Cardiovascular Diseases, Chinese Academy of Medical Sciences & Peking Union Medical College100037, BeijingBeijing Municipality, China
Xuanwu Hospital,Capital Medical University100053, BeijingBeijing Municipality, China

Sponsors and collaborators

Chinese Academy of Medical Sciences, Fuwai Hospital

Lead sponsor