The aim of the study is to further understand whether the use of non-invasive monitoring NIRS (Near Infrared Spectroscopy) is useful in reducing postoperative complications in high-risk patients undergoing elective surgery.
hypertensive patients with American Society of Anesthesiologists (ASA) score≥ 2 with either Age ≥ 65 years or frailty score ≥5
presence of an arterial catheter during anesthesia
planned high-risk surgery (abdominal, vascular, urologic, thoracic one-lung ventilation (OLV) procedures), longer than 60 minutes, in general anesthesia
ability to give informed consent according to International Conference on Harmonization ICH/ Good Clinical Practice (GCP), and national/local regulations
Unable to consent to study inclusion
Language barrier
Severe neurological or psychiatric disease
End-stage dementia
Parallel
Near Infrared Spectroscopy (NIRS)
DeviceThe anesthesiologist will apply optodes before induction of anesthesia and before preoxygenation, to detect baseline NIRS level, NIRS will be monitored continuously up to post-anaesthesia care unit (PACU) discharge, or up to three the investigator's after ICU admission. When a decrease in NIRS value over 10% is detected, or if NIRS value is below 60%, patients will start hemodynamic optimization, to reverse the reduction in NIRS and return to baseline values, according to a predefined protocol.
Standard Care
DeviceControls will be treated according to standard of care, maintaining a MAP≥65 and an adequate cardiac output according to the hemodynamic monitoring chosen by the anesthesiologist (invasive blood pressure monitoring or pulse contour monitors). NIRS will be recorded also in controls, but caring anesthesiologists will be blinded to NIRS.
The overall incidence of perioperative complications (including postoperative cognitive dysfunction and delirium).
Percentage of successful reversal of reduction in NIRS, according to the hemodynamic optimization protocol.
NIRS variations over time, and according to interventions
Percentage of time with NIRS within safety limits (<10% reduction)
Bispectral index (BIS) over time
Mean arterial pressure (MAP) over time
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