Development of Anesthesia Standard Operating Procedure During On-pump Coronary Artery Bypass Grafting Due to Coronary Heart Disease
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of people with postoperative atrial fibrillation
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 44 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age from 44 to 65 years,
- •nn ejection fraction > 30%,
- •operational risk assessment for EuroSCORE II <5%,
- •on-pump coronary artery bypass grafting
排除标准
- •patient's refusal
- •off-pump coronary artery bypass grafting
- •the need for additional intervention on the heart
研究组 & 干预措施
First group
Multimodal low-opioid protocol provided for induction of anesthesia with intravenous (iv) propofol administration using the dosage of 1.5-2 mg/kg at 40 mg in interval of 10-15 seconds, iv fentanyl dosage 1-1.5 μg/kg and iv pipecuronium bromide dosage of 0.1 mg/kg. Before intubation of the trachea, a lidocaine 1 mg / kg bolus was added intravenously, with the simultaneous establishment of a continuous infusion at a dose of 1.5-2 mg/kg/h. All patients were administered a bolus of ketamine (0.5 mg/kg) and were started continuous infusion dexmedetomidine at a dose 0.7 μg/kg/h. If indicated fentanyl was used as additional analgesic during surgery by bolus injection. Depth of anesthesia was monitored with bispectral index; the dosage of sevoflurane from 1,5vol% to 2,5vol% was titrated to maintain BIS values from 40 to 60.
干预措施: Low opioid anesthesia (Drug)
Second group
Routine opioid protocol of anesthesia provided for induction of anesthesia with the iv administration of propofol dosage of 1.5-2 mg/kg at 40 mg in interval of 15-20 seconds, iv fentanyl at a dose of 1-1.5 μg/kg and iv pipecuronium bromide dosage of 0.1 mg/kg. For analgesia, bolus injections of fentanyl were used at a dose of 8-10 μg/kg for the entire duration of the operation, muscle relaxation - pipecuronium bromide at a dose of 0.1 mg/kg. Depth of anesthesia was monitored with bispectral index; the dosage of sevoflurane from 1,5vol% to 2,5vol% was titrated to maintain BIS values from 40 to 60.
干预措施: Low opioid anesthesia (Drug)
结局指标
主要结局
Number of people with postoperative atrial fibrillation
时间窗: immediately after the surgery
Postoperative atrial fibrillation was defined as first appeared in the period immediately after surgery
Number of people with low cardiac output syndrome
时间窗: 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
Duration of mechanical ventilation
时间窗: 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%).
Change of concentration of IL-6 in venous blood plasma immediately after the surgery
时间窗: immediately after surgery
The length of ICU stay
时间窗: immediately after the surgery
次要结局
未报告次要终点
研究者
Maruniak Stepan
Senior Researcher
Heart Institute, Ministry of Health of Ukraine