Cardiac Surgery, General Anesthesia, Goal-directed Therapy, Hemodynamic Instability, Nociceptive Pain, Nol-Index, Remifentanil, Vascular Surgery
Conditions
Brief summary
This study will investigate the potential of guiding remifentanil analgesia during cardiac and vascular surgery in moderate to high risk patients requiring general anesthesia.
Detailed description
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.
Interventions
DEVICENol-Index guided analgesia
Monitor that indicates the level of nociception-antinociception balance
OTHERStandard Analgesia
Administration of remifentanil based guided by heart rate, blood pressure, and experience
Sponsors
Erasme University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Remifentanil requirement | 2 to 8 hours | µg/kg/hour required during general anesthesia |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Norepinephrine requirement | 2 to 8 hours | µg/kg/hour required during general anesthesia |
| nicardipine requirement | 2 to 8 hours | mg/kg/hour required during general anesthesia |
| esmolol requirement | 2 to 8 hours | mg/kg/hour required during general anesthesia |
| Intraoperative hemodynamic instability | 2 to 8 hours | Occurence of hypotension, hypertension, bradycardia or tachycardia |
| Number of patients with 28 day composite and individual adverse outcomes | 28 days | renal failure, cardiac ischemia, ileus, stroke, new onset arrhythmia, etc |
| propofol requirement | 2 to 8 hours | mg/kg/hour required during general anesthesia |
| Systolic Blood Pressure | 2 to 8 hours | systolic blood pressure during anesthesia |
| Diastolic Blood Pressure | 2 to 8 hours | diastolic blood pressure during anesthesia |
| Mean Blood Pressure | 2 to 8 hours | mean blood pressure during anesthesia |
| Cardiac Output | 2 to 8 hours | cardiac output during anesthesia |
| Heart Rate | 2 to 8 hours | Heart rate during anesthesia |
Countries
Belgium
Outcome results
None listed