Maxillofacial Surgery Clinical Trial
Official title:
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.
NCT number | NCT04963036 |
Other study ID # | B0762021210506 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 28, 2021 |
Est. completion date | June 2022 |
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | June 2022 |
Est. primary completion date | June 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | CHU Saint-Pierre | Bruxelles |
Lead Sponsor | Collaborator |
---|---|
Centre Hospitalier Universitaire Saint Pierre |
Belgium,
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* Note: There are 19 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Occurrence 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 |
during surgery | |
Primary | 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) | during surgery | |
Primary | Number of interventions to cure intraoperative hypotension | Number of vasopressor boli or vasopressor infusion dose adjustments | during surgery | |
Primary | Total Time under hypotension thresholds | Hypotension Thresholds ( <65 mmHg or < 75mmHg for patient with history of chronic hypertension) | during surgery | |
Secondary | 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. | up to 48 hours after surgery | |
Secondary | 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. | up to 48 hours after surgery | |
Secondary | 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 | up to 6 months after surgery | |
Secondary | 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 | up to 6 months after surgery | |
Secondary | 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. | up to 4 hours after surgery | |
Secondary | 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). | up to 48 hours after surgery | |
Secondary | 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). | up to 48 hours after surgery | |
Secondary | Length of Intensive Unit Care (IUC) stay | up to 10 Days after surgery | ||
Secondary | Length of hospital stay | up to 15 Days after surgery | ||
Secondary | Adverse Event (blood loss, infection) | up to 15 Days after surgery |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
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