Coronary Artery Disease Clinical Trial
Official title:
Development of Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting Due to Coronary Heart Disease
Verified date | August 2022 |
Source | Heart Institute, Ministry of Health of Ukraine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 120 |
Est. completion date | December 1, 2022 |
Est. primary completion date | October 1, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 44 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Ukraine | Heart Institute Ministry of Health of Ukraine | Kyiv | Kyiv Regio |
Lead Sponsor | Collaborator |
---|---|
Heart Institute, Ministry of Health of Ukraine |
Ukraine,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change of concentration of IL-6 in venous blood plasma immediately after the surgery | immediately after surgery | ||
Primary | Number of people with low cardiac output syndrome | 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 | immediately after the surgery | |
Primary | Number of people with postoperative atrial fibrillation | Postoperative atrial fibrillation was defined as first appeared in the period immediately after surgery | immediately after the surgery | |
Primary | Duration of mechanical ventilation | 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%). | immediately after the surgery | |
Primary | The length of ICU stay | immediately after the surgery |
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