The aim of this study is to determine if Nociception Level (NOL)-guided Remifentanil analgesia, combined with Entropy-guided Propofol anesthesia, has a significant beneficial effect on the incidence of intraoperative hypotension episodes and/or on vasopressor requirements, during long-lasting major surgeries for high risk patients. The investigator will also investigate the effects of guided anesthesia on postoperative Myocardial Injury in Non-cardiac Surgery (MINS) and Postoperative cognitive dysfunction (POCD), amongst other frequent postoperative complications, in this population.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
50
Entropy-guided Anesthesia (Propofol infusion in order to maintain Entropy between 45 and 55) and NOL-guided Analgesia (Remifentanil infusion in order to maintain NOL-Index between 10 and 25).
Entropy-guided Anesthesia (Propofol infusion in order to obtain Entropy between 45 and 55) and Remifentanil infusion at the discretion of the anesthetist in charge, based on current practice: patient vitals (Heart Rate, Blood Pressure, Respiratory Rate…), movements, spontaneous breathing, experience.... In this group, nociception monitor screen will be concealed and the NOL index will not be available for guidance of remifentanil dosing).
CHU Saint-Pierre
Brussels, Belgium
RECRUITINGOccurrence of intraoperative hypotension
Occurrence of intraoperative hypotension is defined by at least 1 minute under the hypotension thresholds. Moderate and Severe Hypotension are respectively defined as a Mean Blood Pressure \<65 mmHg or \<55 mmHg and \<75 or \<65 mmHg for patient with history of chronic hypertension
Time frame: during surgery
Total Vasopressor Dose
Total Vasopressor Dose used throughout the intervention to maintain Arterial Pressure within a pre-defined individualized ranges (≥ 65 mmHg or ≥75 mmHg for patient with history of chronic hypertension, and ≤ 100 mmHg)
Time frame: during surgery
Number of interventions to cure intraoperative hypotension
Number of vasopressor boli or vasopressor infusion dose adjustments
Time frame: during surgery
Total Time under hypotension thresholds
Hypotension Thresholds ( \<65 mmHg or \< 75mmHg for patient with history of chronic hypertension)
Time frame: during surgery
Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T)
Troponin T level measured before surgery, at end of surgery, 4 hours, 8 hours, 24 hours, 36 hours and 48 hours after surgery. The threshold is a postoperative concentration ≥ 20 ng/L with an increase from baseline of at least 5 ng/L, or a postoperative concentration ≥ 65 ng/L.
Time frame: up to 48 hours after surgery
Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate)
Creatinin level measured before surgery, at end of surgery, 24 hours and 48 hours after surgery. The thresholds are defined by the Kidney Disease: Improving Global Outcomes (KDIGO) classification without the oliguria criteria.
Time frame: up to 48 hours after surgery
Postoperative Cognitive Decline (POCD)
POCD will be evaluated by cognitive dysfunction battery tests (written Montreal Cognitive Assessment (MOCA) Test) at days 5,10, 15, hospital discharge, 3 and 6 postoperative months
Time frame: up to 6 months after surgery
PostOperative Delirium (PO Delirium)
PO Delirium will be evaluated by the Confusion Assessment Method (CAM) at days 5, 10, 15, hospital discharge, 3 and 6 postoperative months
Time frame: up to 6 months after surgery
Dosage of Stress Hormones
Adrenocorticotropic Hormone (ACTH) and Cortisol will be measured in blood samples at the end of surgery, at the arrival in the ICU and at 4 hours after surgery.
Time frame: up to 4 hours after surgery
Dosage of Neuro-Inflammatory Markers
Interleukine-6 and Interleukine-8 will be measured in blood and saliva samples before surgery and during the postoperative period (4 hours, 24 hours and 48 hours after surgery).
Time frame: up to 48 hours after surgery
Olfactory Function assessment as an indicator of Neuro-Inflammation
A rapid quantitative olfactory function test, the University of Pennsylvania Smell Identification -Test (UPSIT-Test) will be performed before surgery and during the postoperative period (4 hours, 24 hours and 48 hours after surgery).
Time frame: up to 48 hours after surgery
Length of Intensive Unit Care (IUC) stay
Time frame: up to 10 Days after surgery
Length of hospital stay
Time frame: up to 15 Days after surgery
Adverse Event (blood loss, infection)
Time frame: up to 15 Days after surgery
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