Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery
NCT ID: NCT04137991
Last Updated: 2022-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
48 participants
INTERVENTIONAL
2019-10-10
2021-11-01
Brief Summary
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Detailed Description
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Moderate-to-high risk cardiovascular surgery is associated with perioperative morbidity and mortality. These patients undergo general anesthesia and often require tight blood pressure control (e.g., using norepinephrine titration) to avoid the complications associated with hypotension and reduced cardiac output. Standard analgesia opioid titration to control nociception (i.e., the patient's unconscious response to noxious stimuli) is based on the anesthesiologist's experience and variations in the patient's heart rate and blood pressure. This causes anesthesiologists to often give too much analgesic, which can lead to inhibition of the sympathetic autonomic nervous system, hypotension, and associated side effects. A recently developed nociception monitor, the PMD-200 (Medasense, Israel), is capable of measuring the patient's level of nociception-antinociception balance and can guide opioid administration. This monitor may allow anesthesiologists to administer only the required amount of opioid, which may lead to better hemodynamic stability and better postoperative outcome.
Objectives:
The goal of this study is to determine if titrating analgesia using the Nol-Index, when compared to standard care, leads to decreased infused remifentanil, decreased norepinephrine, increased cardiac output, more stable blood pressure control, and decreased postoperative complications in moderate-to-high risk patients undergoing cardiac or vascular surgery.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Nol-Guided Analgesia Group
In the Nol-Guided Analgesia Group remifentanil effect site concentration will be adapted to maintain the NOL-index between 10 and 25 throughout the anesthetic.
Nol-Index guided analgesia
Monitor that indicates the level of nociception-antinociception balance
Standard Analgesia Group
Remifentanil titration in the Standard Analgesia Group will be left at the anesthesiologists discretion (i.e., guided by heart rate, blood pressure, and experience).
Standard Analgesia
Administration of remifentanil based guided by heart rate, blood pressure, and experience
Interventions
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Nol-Index guided analgesia
Monitor that indicates the level of nociception-antinociception balance
Standard Analgesia
Administration of remifentanil based guided by heart rate, blood pressure, and experience
Eligibility Criteria
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Inclusion Criteria
* ASA 2-4
Exclusion Criteria
* aortic insufficiency
* pacemaker
* implanted defibrillator
* valve surgery
18 Years
80 Years
ALL
No
Sponsors
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Erasme University Hospital
OTHER
Responsible Party
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Principal Investigators
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Luc Barvais, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasme University Hospital
Locations
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Anesthesia Department, Erasme Hospital
Brussels, , Belgium
Countries
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Other Identifiers
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P2019/427
Identifier Type: -
Identifier Source: org_study_id
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