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Clinical Trials/NCT04963036
NCT04963036UnknownNot Applicable

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.

Centre Hospitalier Universitaire Saint Pierre2 sites in 1 country50 target enrollmentStarted: July 28, 2021Last updated:
Conditions

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)

Investigators

Sponsor
Centre Hospitalier Universitaire Saint Pierre
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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