The intraoperative hemodynamic management of the patients assigned to this arm will be left to the discretion of the anesthesiologist, without any indication as to the intraoperative hemodynamic strategy to be adopted.

The anesthesiologist will have as hemodynamic target for patients assigned to this arm the maintenance of mean arterial blood pressure within 10% of the baseline blood pressure value (recorded at the preoperative evaluation). The strategy to reach this hemodynamic target will be left to the clinical judgment of the anaesthesiologist in charge. The possible strategies include a vasoconstrictor agent (either phenylephrine, ephedrine, epinephrine, norepinephrine or dopamine), intravenous fluids, patient's positioning or reduction of depth of anesthesia.

Subjects assigned to this arm will undergo the same geriatric, neuropsychologic and audiologic evaluations administered to patients of the "Standard-of-Care" and "Treatment" arms at the same time points (baseline, 3 months and 1 year). These subjects will not undergo any surgical procedure and will therefore not be evaluated for post-operative complications or delirium occurrence.

Post-operative Cognitive Dysfunction

The anaesthesiologist is requested to maintain intraoperative mean arterial blood pressure of the patient within 10% of the baseline mean arterial blood pressure (recorded during the preoperative evaluation) of that patient. In order to reach this hemodynamic target the anesthesiologist can choose between one or more of the following four sub-interventions:
vasoconstrictor agents (either phenylephrine, ephedrine, epinephrine, norepinephrine or dopamine)
intravenous fluids
patient's positioning
reduction of depth of anesthesia

Hemodynamic target

Phenylephrine 0.1-0.2 mg intravenous bolus

Phenylephrine

A crystalloid fluid bolus is given intravenously (5-10 ml/kg)

Intravenous fluids

The operating table is positioned so that the patient's head lies below the level of the patient's feet (Trendelenburg position) in order to increase venous return

Patient's positioning

The halogenated anesthetic vapor's inspiratory fraction is decreased in order to reduce the associated peripheral vasodilation

Reduction of depth of anesthesia

Ephedrine

Epinephrine

Norepinephrine 0.01 - 0.1 mcg/kg/min intravenous continuous infusion

Norepinephrine

Dopamine 5 - 10 mcg/kg/min intravenous continuous infusion

Dopamine

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; Via F. Sforza 35

Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly

Effect of Target Intraoperative Blood Pressure on the Incidence of Post-operative Cognitive Dysfunction in Patients Aged 75 and Older Undergoing General Anesthesia for Non-cardiac Surgery: an International Multicenter Randomized Controlled Trial

For each of the neuropsychological tests a Z-score will be calculated. The Z score represents the magnitude of the deviation (in number of standard deviations) in the test results from the reference (Control Group).
The Z-score is calculated as the difference between the baseline and the 3 months test result for a patient, corrected for the expected difference (the mean difference for that test observed in the Control Group), divided by the standard deviation of the mean difference for that test observed in the Control Group.
From the Z-scores of the single tests a combined Z-score can be calculated. Patients in whom the difference (worsening) in the score at 3 months to the score at baseline in at least 2 tests will be greater than 2 standard deviations from the expected difference (i.e. Z-score ≥ 2 in at least 2 tests), will be diagnosed with POCD. Also patients in which the combined Z-score will be equal or greater than 2 will be diagnosed with POCD.

For each of the neuropsychological tests a Z-score will be calculated. The Z score represents the magnitude of the deviation (in number of standard deviations) in the test results from the reference (Control Group).
The Z-score is calculated as the difference between the baseline and the 1 year test result for a patient, corrected for the expected difference (the mean difference for that test observed in the Control Group), divided by the standard deviation of the mean difference for that test observed in the Control Group.
From the Z-scores of the single tests a combined Z-score can be calculated. Patients in whom the difference (worsening) in the score at 1 year to the score at baseline in at least 2 tests will be greater than 2 standard deviations from the expected difference (i.e. Z-score ≥ 2 in at least 2 tests), will be diagnosed with POCD. Also patients in which the combined Z-score will be equal or greater than 2 will be diagnosed with POCD.

During the first postoperative week all patients will be evaluated on a daily basis for delirium occurrence by the CAM-ICU scale (Confusion Assessment Method for the ICU).
The CAM-ICU scale defines delirium by the simultaneous occurrence of items 1, 2 and one between items 3 and 4. Items are listed below:
Acute alteration of mental status or fluctuating mental status in the preceding 24 hours
Inattention
Altered level of consciousness (Richmond Agitation and Sedation Scale, RASS ≠ 0)
Disorganized thinking

Clinical evaluation of worsening in hearing function

Number of days of hospitalization after the surgical operation

During the first postoperative week patients will be assessed on a daily basis for the occurrence of cardio-pulmonary (acute myocardial infarction, congestive heart failure, pulmonary embolism, cardiac arrest, atrial fibrillation, pneumonia), neurologic (ischemic or hemorrhagic stroke), renal or hemorrhagic complications.

Clinical evaluation of worsening of vestibular function

The incidence of the primary and secondary outcomes will be assessed in the Standard of Care arm vs the patients in the Treatment arm who spent at least 75% of the anesthesia time within the hemodynamic target (within 10% of baseline mean arterial blood pressure)

The incidence of the primary and secondary outcomes will be assessed in relation to the absolute and relative time spent in any category of blood pressure defined as "hypotension" (either mild, moderate or severe) and to the absolute and relative time spent in each category of hypotension (mild, moderate or severe). This analysis will be performed on the entire patients population, irrespective of allocation arm.

The incidence of the primary and secondary outcomes will be assessed in relation to the absolute and relative time spent with cerebral desaturation (non-invasive cerebral saturimetry < 50%) and to the magnitude of cerebral desaturation episodes. This analysis will be performed on the entire patients population, irrespective of allocation arm.

The incidence of the primary and secondary outcomes will be assessed in the following subgroup of patients:
age stratification categories (age 75-79; 80-84; ≥ 85) surgery stratification categories (minor vs major surgery) education level (<8 years; 8-13 years; > 13 years education) normotensive vs hypertensive patients non-frail patients vs cognitive frail patients

Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico

cases retrospectively reported the last 20 years

Diffusion tensor magnetic resonance imaging of the brain:
new cases prospectively reported

- serum sample - cerebrospinal fluid sample - DNA sample - RNA sample - Peripheral Blood Mononuclear Cell sample

SUSAC's Syndrome

Encephalopathy

Hearing Loss

Retinal Artery Branch Occlusions

Diffusion tensor magnetic resonance imaging of the brain will be obtained to more carefully study the cerebral microvasculopathy of the disease.

Diffusion tensor magnetic resonance imaging of the brain

Hospital BICHAT

Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome

Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome (RETINOCOCHLEOCEREBRAL Vasculopathy)

To characterize the epidemiological, clinical, and etiological of SUSAC's Syndrome

all samples from each patient will be collected to study potential autoimmune, thrombotic and infectious markers

Assistance Publique - Hôpitaux de Paris

Blood taking for glaucoma genetics analysis shall be performed.

hearing loss/infarkt

Target Hemodynamics and Brain Injury During General Anesthesia in the Elderly

Epidemiological, Clinical and Etiological Features of SUSAC's Syndrome

Analysis of Clinical Profiles of Chinese Patients With Normal Tension Glaucoma

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