This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
48
Monitor that indicates the level of nociception-antinociception balance
Administration of remifentanil based guided by heart rate, blood pressure, and experience
Anesthesia Department, Erasme Hospital
Brussels, Belgium
Remifentanil requirement
µg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
Norepinephrine requirement
µg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
propofol requirement
mg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
nicardipine requirement
mg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
esmolol requirement
mg/kg/hour required during general anesthesia
Time frame: 2 to 8 hours
Intraoperative hemodynamic instability
Occurence of hypotension, hypertension, bradycardia or tachycardia
Time frame: 2 to 8 hours
Number of patients with 28 day composite and individual adverse outcomes
renal failure, cardiac ischemia, ileus, stroke, new onset arrhythmia, etc
Time frame: 28 days
Heart Rate
Heart rate during anesthesia
Time frame: 2 to 8 hours
Systolic Blood Pressure
systolic blood pressure during anesthesia
Time frame: 2 to 8 hours
Diastolic Blood Pressure
diastolic blood pressure during anesthesia
Time frame: 2 to 8 hours
Mean Blood Pressure
mean blood pressure during anesthesia
Time frame: 2 to 8 hours
Cardiac Output
cardiac output during anesthesia
Time frame: 2 to 8 hours
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.