NCT05514652

Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting

Development of Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting Due to Coronary Heart Disease

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Heart Institute, Ministry of Health of Ukraine · Academic / Other
• Sex: All
• Age: 44 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease
• Low Cardiac Output Syndrome
• Atrial Fibrillation
• Postoperative Complications

Interventions

Type	Name	Description
DRUG	Low opioid anesthesia	Multimodal low-dose opioid protocol for anesthesia based on ketamine, lidocaine and dexmedetomidine

Timeline

• Start date: 2018-12-01
• Primary completion: 2021-10-01
• Completion: 2022-12-01
• First posted: 2022-08-24
• Last updated: 2022-08-24

Locations

1 site across 1 country: Ukraine