Anesthesia Department, Erasme Hospital
Brussels, Belgium
NCT Number: NCT04137991
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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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Brussels, Belgium
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Monitor that indicates the level of nociception-antinociception balance
Administration of remifentanil based guided by heart rate, blood pressure, and experience
Time frame: 2 to 8 hours
µg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
µg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
mg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
mg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
mg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
Occurence of hypotension, hypertension, bradycardia or tachycardia
Time frame: 28 days
renal failure, cardiac ischemia, ileus, stroke, new onset arrhythmia, etc
Time frame: 2 to 8 hours
Heart rate during anesthesia
Time frame: 2 to 8 hours
systolic blood pressure during anesthesia
Time frame: 2 to 8 hours
diastolic blood pressure during anesthesia
Time frame: 2 to 8 hours
mean blood pressure during anesthesia
Time frame: 2 to 8 hours
cardiac output during anesthesia
Erasme University Hospital
Other
Nol-Index Guided Remifentanil Analgesia Versus Standard Analgesia During Moderate-to-High Risk Cardiovascular Surgery: a Randomized Controlled Trial
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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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