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Completed

NCT Number: NCT04137991

Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery

This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Anesthesia Department, Erasme Hospital

Brussels, Belgium

About this study

Justification:

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • moderate-to-high risk cardiac or vascular surgery
  • ASA 2-4

Exclusion criteria

  • chronic arrhythmia (e.g. atrial fibrillation)
  • aortic insufficiency
  • pacemaker
  • implanted defibrillator
  • valve surgery

Treatment and study plan

Nol-Index guided analgesia

Device

Monitor that indicates the level of nociception-antinociception balance

Standard Analgesia

Other

Administration of remifentanil based guided by heart rate, blood pressure, and experience

Primary outcomes

  1. Remifentanil requirement

    Time frame: 2 to 8 hours

    µg/kg/hour required during general anesthesia

Secondary outcomes

  1. Norepinephrine requirement

    Time frame: 2 to 8 hours

    µg/kg/hour required during general anesthesia

  2. propofol requirement

    Time frame: 2 to 8 hours

    mg/kg/hour required during general anesthesia

  3. nicardipine requirement

    Time frame: 2 to 8 hours

    mg/kg/hour required during general anesthesia

  4. esmolol requirement

    Time frame: 2 to 8 hours

    mg/kg/hour required during general anesthesia

  5. Intraoperative hemodynamic instability

    Time frame: 2 to 8 hours

    Occurence of hypotension, hypertension, bradycardia or tachycardia

  6. Number of patients with 28 day composite and individual adverse outcomes

    Time frame: 28 days

    renal failure, cardiac ischemia, ileus, stroke, new onset arrhythmia, etc

  7. Heart Rate

    Time frame: 2 to 8 hours

    Heart rate during anesthesia

  8. Systolic Blood Pressure

    Time frame: 2 to 8 hours

    systolic blood pressure during anesthesia

  9. Diastolic Blood Pressure

    Time frame: 2 to 8 hours

    diastolic blood pressure during anesthesia

  10. Mean Blood Pressure

    Time frame: 2 to 8 hours

    mean blood pressure during anesthesia

  11. Cardiac Output

    Time frame: 2 to 8 hours

    cardiac output during anesthesia

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Official study title

Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery: a Randomized Controlled Trial

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Oct 24, 2019
Registry last updated
Jul 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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