Taking Brain Monitoring to the Next Level
Condition: Postoperative Cognitive Dysfunction; Postoperative Delirium; Obstructive Sleep Apnea
MeSH terms: Sleep Apnea, Obstructive; Emergence Delirium; Postoperative Cognitive Complications; Cognitive Dysfunction
Study type: Interventional

Summary: 
      This one arm clinical study will assess the impact of a goal directed therapy intervention,
      aiming at optimizing depth of anesthesia and intraoperative blood pressure on the incidence
      of postoperative cognitive dysfunction and delirium relative to a standardized anesthetic
      plan. We will enroll 60 patients and will measure the neurocognitive status (MoCA test) of
      patients before and after surgery (at discharge, within 2 weeks after surgery and 6 months
      after surgery) to determine the relative impact of anesthetic care on the development of
      postoperative delirium and cognitive decline. All patients will have a brain scan (fMRI)
      before and after surgical intervention. Patients will also be asked to participate in an
      optional blood draw which will take place during their brain imaging visit and post
      operatively (within 2 days after surgery).
    

Detailed description: 
      This study will test the hypothesis that a goal directed therapy intervention, which
      optimizes depth of anesthesia and intraoperative blood pressure can decrease the incidence of
      postoperative neurocognitive dysfunction

      Subjects will be recruited for the study and the protocol explained. In addition to standard
      American Society of Anesthesiologists (ASA) monitoring, we will monitor continuous
      non-invasive blood pressure and 4 lead electroencephalogram (EEG) channels. Patients will
      receive standardized anesthesia care in addition to a goal directed therapy hemodynamic
      management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).

      Neurocognitive testing: In order to assess general cognitive function, the Montreal Cognitive
      Assessment test will be used. Cognitive function will be measured preoperatively and
      postoperatively at discharge, 1 month and 6 months after surgery. For delirium measurement,
      we will administer daily the Confusion Assessment Method (CAM-ICU) for up to 3 days.

      The Montreal Cognitive Assessment (MoCA) is a screening tool to assess mild cognitive
      dysfunction. It assesses different cognitive domains: attention and concentration, executive
      functions, memory, language, visuoconstructionals skills, conceptual thinking, calculations,
      and orientation. Time to administer the MoCA is approximately 10 minutes. The total possible
      score is 30 points; a score of 26 or above is considered normal.

      The Wide Range Assessment of Memory and Learning (WRAML2) is a broad-based memory battery
      that provides a flexible measure of memory functioning and learning and takes approximately
      45-60 minutes to administer. This assessment will be conducted at the first MRI visit and at
      the 6 month follow up.

      The Confusion Assessment Method for the ICU (CAM-ICU) screens for the development of delirium
      and assesses four features: 1) acute change or fluctuation in mental status from baseline, 2)
      inattention, 3) altered level of consciousness, and 4) disorganized thinking. The CAM-ICU is
      positive, and the patient is considered to have delirium, if features 1 and 2 and either
      feature 3 or 4 are present.

      Brain imaging: The timing of pre-operative brain imaging will be as allowed by patient
      factors and scanner availability, typically less than 15 days before surgery, when the
      patient comes for the preoperative evaluation, and postoperatively within 2 weeks after
      surgery.

      Optional Blood Draws: Patients will be asked to provide 2 optional blood samples, drawn the
      day of their brain imaging visit and post-operatively (within 2 days). These samples will be
      used to asses blood inflammatory biomarkers in obstructive sleep apnea (OSA) subjects and
      non-OSA subjects between baseline and post-surgery.
    

Intervention name(s): Goal directed therapy (GDT)
Intervention type(s): Other
Intervention description(s): Goal directed therapy (GDT) hemodynamic management (MAP > 60 mmHg) and processed EEG-guided anesthesia (PSI targeted between 30-50).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: goal directed therapy (GDT); magnetic resonance imaging (MRI); neurocognitive testing