Clinical trial NCT04963036: Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Head and Neck Surgery
Maxillofacial Surgery
Keywords: Nociception
Entropy
Analgesia
Goal Directed Anesthesia Therapy (GDAT)
Remifentanil
Intraoperative Hypotension
Myocardial Injury in Non-Cardiac Surgery (MINS)
Postoperative Cognitive Dysfunction (POCD)
Lead sponsor: Centre Hospitalier Universitaire Saint Pierre
Sponsor class: OTHER
First posted: 2021-07-15
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Occurrence of intraoperative hypotension
timeFrame: during surgery
measure: Total Vasopressor Dose
timeFrame: during surgery
measure: Number of interventions to cure intraoperative hypotension
timeFrame: during surgery
measure: Total Time under hypotension thresholds
timeFrame: during surgery
Secondary outcomes:
measure: Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T)
timeFrame: up to 48 hours after surgery
measure: Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate)
timeFrame: up to 48 hours after surgery
measure: Postoperative Cognitive Decline (POCD)
timeFrame: up to 6 months after surgery
measure: PostOperative Delirium (PO Delirium)
timeFrame: up to 6 months after surgery
measure: Dosage of Stress Hormones
timeFrame: up to 4 hours after surgery
measure: Dosage of Neuro-Inflammatory Markers
timeFrame: up to 48 hours after surgery
measure: Olfactory Function assessment as an indicator of Neuro-Inflammation
timeFrame: up to 48 hours after surgery
measure: Length of Intensive Unit Care (IUC) stay
timeFrame: up to 10 Days after surgery
measure: Length of hospital stay
timeFrame: up to 15 Days after surgery
measure: Adverse Event (blood loss, infection)
timeFrame: up to 15 Days after surgery
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: CHU Saint-Pierre
Study officials:
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Panayota Kapessidou, MD,PhD
role: STUDY_DIRECTOR
affiliation: University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)
name: Mehdi M'rini, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Ruetzler K, Khanna AK, Sessler DI. Myocardial Injury After Noncardiac Surgery: Preoperative, Intraoperative, and Postoperative Aspects, Implications, and Directions. Anesth Analg. 2020 Jul;131(1):173-186. doi: 10.1213/ANE.0000000000004567.
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