Impact of Nociception Level (NOL)-Guided Remifentanil Infusion on Intraoperative Arterial Pressure and Vasopressor Necessity

Not Applicable

• Conditions: Head and Neck Surgery; Maxillofacial Surgery
• Interventions: Other: Entropy and NOL-Guided Goal Directed Anesthesia; Other: Standard of Care Group (Entropy and blinded NOL)

• Registration Number: NCT04963036
• Lead Sponsor: Centre Hospitalier Universitaire Saint Pierre

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-14
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-05
• Study First Posted: 2021-07-15
• Study Start: 2021-07-28
• Last Update Submitted: 2022-04-14
• Last Update Posted: 2022-04-15
• Primary Completion: 2022-06
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Entropy and NOL-Guided Goal Directed Anesthesia	Entropy and NOL-Guided Goal Directed Anesthesia	-
Standard of Care Group (Entropy and blinded NOL)	Standard of Care Group (Entropy and blinded NOL)	-

Primary Outcome Measures

Name	Time	Method
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
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)
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)

Secondary Outcome Measures

Name	Time	Method
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
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.
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.
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).
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	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 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
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).
Length of Intensive Unit Care (IUC) stay	up to 10 Days after surgery
Length of hospital stay	up to 15 Days after surgery

Trial Locations

Locations (1)

CHU Saint-Pierre; 🇧🇪 Bruxelles, Belgium