Atrial Fibrillation, Coronary Artery Disease, Low Cardiac Output Syndrome, Postoperative Complications
Conditions
Keywords
coronary artery bypass grafting, cardiopulmonary bypass, coronary artery disease, low cardiac output syndrome, low-dose opioid anesthesia, postoperarive atrial fibrillation, IL-6
Brief summary
Background: Despite improvements in surgical and anesthesia procedures over the past 15 years complications during cardiac surgery still remain high. Bridgewater B et al. describes mortality during on-pump coronary artery bypass grafting (CABG) at 2%-3%, and the rate postoperative complications about 20%-30%. At the same time, the standard of care in patients undergoingon-pump CABG is not fully established. Hypothesis, Research Need: Use of multimodal low-dose opioid anesthesia during CABG decreases inflammatory response and the incidence of early postoperative cardiac complications due to a reduction in interleukin-6. Methodology: According to anesthesia standard protocol, all patients were divided into two groups - study group with multimodal low-dose opioid anesthesia (60 patients) and control group with a high-dose opioid anesthesia (60 patients). Primary (IL-6 at the end of the operation) and secondary clinical outcomes (postoperative atrial fibrillation (POAF), low cardiac output syndrome (LCOS), duration of mechanical ventilation (MV), length of intensive care unit (ICU) stay, length of hospital stay) were compared between the groups. Analysis Tools: Clinical observations; instrumental research methods (electrocapdiography, echocardiography); labs (blood gases, hemoglobin, electrolytes); enzyme-linked immunosorbent assay (IL-6); statistical (Student's t-test, Mann-Whitney U test, χ2-test, correlation analysis). Expected Outcomes: Use of multimodal low-dose opioid anesthesia during CABG will decrease inflammatory response (lower levels of IL-6 at the end of the surgery) and the incidence of early postoperative cardiac complications, expressed as lower incidence of LCOS and POAF, lower duration of MV and lower length of ICU stay.
Interventions
DRUGLow opioid anesthesia
Multimodal low-dose opioid protocol for anesthesia based on ketamine, lidocaine and dexmedetomidine
Sponsors
Heart Institute, Ministry of Health of Ukraine
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
44 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age from 44 to 65 years, * nn ejection fraction \> 30%, * operational risk assessment for EuroSCORE II \<5%, * on-pump coronary artery bypass grafting
Exclusion criteria
* patient's refusal * off-pump coronary artery bypass grafting * the need for additional intervention on the heart
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of concentration of IL-6 in venous blood plasma immediately after the surgery | immediately after surgery | — |
| Number of people with low cardiac output syndrome | immediately after the surgery | Postoperative low cardiac output syndrome (LCOS) was defined as hemodynamic instability requiring continued pharmacologic support with 2 inotropic medications (epinephrine, milrinone, dobutamine) on postoperative day 1 |
| Number of people with postoperative atrial fibrillation | immediately after the surgery | Postoperative atrial fibrillation was defined as first appeared in the period immediately after surgery |
| Duration of mechanical ventilation | immediately after the surgery | The decision about the extubation was made on the basis of following clinical criteria: recovering from muscle relaxation and anesthesia; patients is easy to rouse, neurologically intact, lift head and sticks out tongue; stable hemodynamics (heart rate and blood pressure are within ordered parameters, bleeding is controlled); spontaneous muscle movement with stable respiratory rate and adequate oxygenation, which was confirmed by arterial blood gases (SaO2 \>92 %, on FiO2 \<50%). |
| The length of ICU stay | immediately after the surgery | — |
Countries
Ukraine
Outcome results
None listed