Clinical trial NCT05514652: Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting
Official title: Development of Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting Due to Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Low Cardiac Output Syndrome
Atrial Fibrillation
Postoperative Complications
Keywords: coronary artery bypass grafting
cardiopulmonary bypass
coronary artery disease
low cardiac output syndrome
low-dose opioid anesthesia
postoperarive atrial fibrillation
IL-6
Lead sponsor: Heart Institute, Ministry of Health of Ukraine
Sponsor class: OTHER
First posted: 2022-08-24
Enrollment: 120
Sex: ALL
Minimum age (years): 44
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change of concentration of IL-6 in venous blood plasma immediately after the surgery
timeFrame: immediately after surgery
measure: Number of people with low cardiac output syndrome
timeFrame: immediately after the surgery
measure: Number of people with postoperative atrial fibrillation
timeFrame: immediately after the surgery
measure: Duration of mechanical ventilation
timeFrame: immediately after the surgery
measure: The length of ICU stay
timeFrame: immediately after the surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Heart Institute Ministry of Health of Ukraine
state: Kyiv Regio
Study officials:
References: