Head and Neck Surgery, Maxillofacial Surgery
Conditions
Keywords
Nociception, Entropy, Analgesia, Goal Directed Anesthesia Therapy (GDAT), Remifentanil, Intraoperative Hypotension, Myocardial Injury in Non-Cardiac Surgery (MINS), Postoperative Cognitive Dysfunction (POCD)
Brief summary
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.
Interventions
OTHEREntropy and NOL-Guided Goal Directed Anesthesia
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).
OTHERStandard of Care Group (Entropy and blinded NOL)
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).
Sponsors
Centre Hospitalier Universitaire Saint Pierre
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≥18 * Elective high-risk head and neck or maxillo-facial surgery
Exclusion criteria
* Patient refusal * Reduced ejection fraction below 40% and heart failure * History of atrial Fibrillation, pulmonary embolism, recent cardioversion, recent cardiac ischemic episode, chronic hypotension, chronic kidney insufficiency (serum creatinine \> 1.5) * Septic state * Baseline heart-rate \< 50 or \> 90 bpm * History of psychiatric disease or medication
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of intraoperative hypotension | during surgery | 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 |
| Total Vasopressor Dose | during surgery | 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) |
| Number of interventions to cure intraoperative hypotension | during surgery | Number of vasopressor boli or vasopressor infusion dose adjustments |
| Total Time under hypotension thresholds | during surgery | Hypotension Thresholds ( \<65 mmHg or \< 75mmHg for patient with history of chronic hypertension) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dosage of Stress Hormones | up to 4 hours after surgery | 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. |
| Dosage of Neuro-Inflammatory Markers | up to 48 hours after surgery | 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). |
| Olfactory Function assessment as an indicator of Neuro-Inflammation | up to 48 hours after surgery | 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). |
| Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T) | up to 48 hours after surgery | 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. |
| Length of hospital stay | up to 15 Days after surgery | — |
| Adverse Event (blood loss, infection) | up to 15 Days after surgery | — |
| Length of Intensive Unit Care (IUC) stay | up to 10 Days after surgery | — |
| Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate) | up to 48 hours after surgery | 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. |
| Postoperative Cognitive Decline (POCD) | up to 6 months after surgery | 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 |
| PostOperative Delirium (PO Delirium) | up to 6 months after surgery | PO Delirium will be evaluated by the Confusion Assessment Method (CAM) at days 5, 10, 15, hospital discharge, 3 and 6 postoperative months |
Countries
Belgium
Contacts
Primary ContactPanayota Kapessidou, MD,PhD
Backup ContactMehdi M'rini, MD
Outcome results
None listed