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

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05514652
• Other study ID #: 20180001
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: December 1, 2022

Study information

• Verified date: August 2022
• Source: Heart Institute, Ministry of Health of Ukraine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Low opioid anesthesia
Multimodal low-dose opioid protocol for anesthesia based on ketamine, lidocaine and dexmedetomidine

Locations

Country	Name	City	State
Ukraine	Heart Institute Ministry of Health of Ukraine	Kyiv	Kyiv Regio

Sponsors (1)

Lead Sponsor	Collaborator
Heart Institute, Ministry of Health of Ukraine

Country where clinical trial is conducted

Ukraine, 

Outcome

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