Impact of Nociception Level (NOL)-Guided Remifentanil Infusion and Entropy-guided Propofol Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity A Prospective, Randomized, Controlled Trial.
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Occurrence of intraoperative hypotension
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Outcomes
Primary Outcomes
Occurrence of intraoperative hypotension
Time Frame: 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
Number of interventions to cure intraoperative hypotension
Time Frame: during surgery
Number of vasopressor boli or vasopressor infusion dose adjustments
Total Time under hypotension thresholds
Time Frame: during surgery
Hypotension Thresholds ( \<65 mmHg or \< 75mmHg for patient with history of chronic hypertension)
Total Vasopressor Dose
Time Frame: 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)
Secondary Outcomes
- Postoperative Cognitive Decline (POCD)(up to 6 months after surgery)
- Dosage of Stress Hormones(up to 4 hours after surgery)
- Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T)(up to 48 hours after surgery)
- Olfactory Function assessment as an indicator of Neuro-Inflammation(up to 48 hours after surgery)
- Adverse Event (blood loss, infection)(up to 15 Days after surgery)
- Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate)(up to 48 hours after surgery)
- PostOperative Delirium (PO Delirium)(up to 6 months after surgery)
- Dosage of Neuro-Inflammatory Markers(up to 48 hours after surgery)
- Length of Intensive Unit Care (IUC) stay(up to 10 Days after surgery)
- Length of hospital stay(up to 15 Days after surgery)