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

April 14, 2022 updated by: Centre Hospitalier Universitaire Saint Pierre

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.

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1000
        • Recruiting
        • CHU Saint-Pierre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Entropy and NOL-Guided Goal Directed Anesthesia
Other: Entropy and NOL-Guided Goal Directed Anesthesia
Entropy-guided Anesthesia (Propofol infusion in order to maintain Entropy between 45 and 55) and NOL-guided Analgesia (Remifentanil infusion in order to maintain NOL-Index between 10 and 25).
ACTIVE_COMPARATOR: Standard of Care Group (Entropy and blinded NOL)
Other: Standard of Care Group (Entropy and blinded NOL)

Entropy-guided Anesthesia (Propofol infusion in order to obtain Entropy between 45 and 55) and Remifentanil infusion at the discretion of the anesthetist in charge, based on current practice: patient vitals (Heart Rate, Blood Pressure, Respiratory Rate…), movements, spontaneous breathing, experience....

In this group, nociception monitor screen will be concealed and the NOL index will not be available for guidance of remifentanil dosing).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
during surgery
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)
during surgery
Number of interventions to cure intraoperative hypotension
Time Frame: during surgery
Number of vasopressor boli or vasopressor infusion dose adjustments
during surgery
Total Time under hypotension thresholds
Time Frame: during surgery
Hypotension Thresholds ( <65 mmHg or < 75mmHg for patient with history of chronic hypertension)
during surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Myocardial Injury in Non-Cardiac Surgery (MINS) marker (Troponin T)
Time Frame: 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.
up to 48 hours after surgery
Postoperative Acute Kidney Injury (AKI) marker (creatinin/Glomerular Filtration Rate)
Time Frame: 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.
up to 48 hours after surgery
Postoperative Cognitive Decline (POCD)
Time Frame: 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
up to 6 months after surgery
PostOperative Delirium (PO Delirium)
Time Frame: 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
up to 6 months after surgery
Dosage of Stress Hormones
Time Frame: 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.
up to 4 hours after surgery
Dosage of Neuro-Inflammatory Markers
Time Frame: 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).
up to 48 hours after surgery
Olfactory Function assessment as an indicator of Neuro-Inflammation
Time Frame: 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).
up to 48 hours after surgery
Length of Intensive Unit Care (IUC) stay
Time Frame: up to 10 Days after surgery
up to 10 Days after surgery
Length of hospital stay
Time Frame: up to 15 Days after surgery
up to 15 Days after surgery
Adverse Event (blood loss, infection)
Time Frame: up to 15 Days after surgery
up to 15 Days after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Saint Pierre

Investigators

  • Principal Investigator: Mehdi M'rini, MD, University Hospital Saint-Pierre (CHU Saint-Pierre), Université Libre de Bruxelles (ULB)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 28, 2021

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

June 1, 2022

Study Registration Dates

First Submitted

June 14, 2021

First Submitted That Met QC Criteria

July 5, 2021

First Posted (ACTUAL)

July 15, 2021

Study Record Updates

Last Update Posted (ACTUAL)

April 15, 2022

Last Update Submitted That Met QC Criteria

April 14, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B0762021210506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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