Adding Lidocaine to Custodiol® Cardioplegia to Decrease Post-bypass Ventricular Arrhythmias in Adult Patients Undergoing Coronary Artery Bypass Grafting (CABG) Surgery; A Prospective Randomized Double-Blinded Clinical Trial.
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- incidence of ventricular fibrillation (VF)
研究概览
简要总结
The Bretschneider solution, also known as Custodiol, has been widely used in open-heart surgery requiring cardiopulmonary bypass (CPB) since its introduction in 1970. Custodiol is widely favored by cardiac surgeons, being administered as a single dose, and is supposed to offer myocardial protection for up to three hours, permitting an uninterrupted surgical time, especially for intricate procedures The literature continues to debate the superiority of custodial and other cardioplegic solutions, such as the Del Nido and St. Thomas solutions, regarding both short-term and long-term outcomes. Clinical trials and daily practice showed that the use of custodial cardioplegic solution is associated with increased incidences of ventricular arrhythmias, and subsequently, the use of a defibrillator after Aortic Cross Clamp (ACC) removal at the end of CPB when compared to other types of cardioplegia solutions .One of the reasons for this difference mentioned in the literature is the lidocaine contained in other types of cardioplegic solutions. Lidocaine acts as a membrane stabilizer by blocking rapid sodium channels in the heart, thus preventing arrhythmias, in addition to its ability to inhibit calcium influx, which is the primary cause of ischemic-reperfusion injury.
Based on these data, the investigators hypothesize that the increased incidence of Ventricular arrhythmias with the use of Custodiol compared to other solutions, such as St Thomas and Del Nido, may be attributed to the absence of lidocaine. Although Custodiol contains tryptophan as a membrane-stabilizing component, it may be beneficial to add lidocaine to the Custodiol mixture to decrease the incidence of VF after cross-clamp removal in adult patients undergoing elective CABG.
详细描述
After Ethical Review Board of Fayoum University Hospital (FUH) approval and clinicaltrials.gov registration, all patients scheduled for isolated on-pump Coronary Artery Bypass Grafting (CABG) surgery in FUH starting from August 2025 will be enrolled in the study by signing a written informed consent until the sample size is fulfilled. This randomized double-blinded clinical trial will be reported following the tenets of the Declaration of Helsinki and the Consolidated Standards of Reporting Trials (CONSORT) 2025-updated statement.
Patients will be randomized into two equal groups (1:1 allocation) using a computer-generated random number that will be enclosed in a sealed opaque envelope opened by an anesthesiologist, who is responsible for preparing the cardioplegia solution outside the OR and will not be involved in patient management or data collection.
According to each envelope, the Study solution will be either standard Custodiol cardioplegia solution (manufactured by Dr. Franz Köhler Chemie GmbH, Bensheim, Germany), punctured at the injection port with a 10-cc syringe for blinding (Group C), or the modified solution prepared by adding 6.5 ml of 2% lidocaine (Lidocaine HCL -Sunny Pharmaceutical) to each 1 L bag of Custodiol (Group L), using a 10-cc syringe. According to the patient's weight, one or two 1-L solutions will be prepared (calculated at 20 ml/kg, with a maximum of 2 L), kept at 5-8°C, and handed to the cardiothoracic anesthesia team when ordered. Patients, cardiothoracic surgeons, anesthesiologists, and data collectors will be blinded to group allocation until the end of the study.
All patients will be preoperatively examined and investigated by complete blood count, coagulation profile, liver and kidney functions, and electrolytes. A chest x-ray, Electrocardiography (ECG), echocardiography, Carotid arterial duplex, and Coronary angiography will be routinely ordered. Patients will receive an intramuscular injection of 10 mg morphine on the morning of the operation Upon arrival at OR, Standard monitoring will be applied, involving a 5-lead ECG and pulse oximetry. Blood pressure will be monitored through a 20-G cannula inserted into either the right or left radial artery under local anesthesia. Atracurium (0.5 mg/kg), midazolam (2-5 mg), fentanyl (2-5 μg/kg), and propofol (1-2 mg/kg) will be used to induce general anesthesia following pre-oxygenation.
After tracheal intubation, patients will be mechanically ventilated with an Oxygen and air mixture, maintaining normocapnia confirmed by capnogram and arterial blood gas analysis. A urinary catheter, an esophageal temperature probe, and a right internal jugular triple-lumen central venous catheter will be inserted. Inhalational isoflurane (0.4 to 1 %) and atracurium infusion at 0.5 mg/kg/h will be used to maintain anesthesia and muscle relaxation. A 50-100 µg/kg/min propofol infusion will replace isoflurane inhalation during extracorporeal circulation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will be randomized into two equal groups (1:1 allocation) using a computer-generated random number that will be enclosed in a sealed opaque envelope opened by an anesthesiologist, who is responsible for preparing the cardioplegia solution outside the OR and will not be involved in patient management or data collection.
Patients, cardiothoracic surgeons, anesthesiologists, and data collectors will be blinded to group allocation until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients scheduled for elective Coronary artery bypass grafting surgery
排除标准
- •Emergency or Redo surgery.
- •Baseline rhythm other than sinus rhythm
- •Any degree of heart block, bundle branch block or hemiblock
- •Known allergy to lidocaine.
- •Chronic kidney disease.
- •Hepatic impairment.
- •Severe psychiatric illness.
研究组 & 干预措施
Lidocaine and Custodiol group
the modified solution prepared by adding 6.5 ml of 2% lidocaine (Lidocaine HCL -Sunny Pharmaceutical) to each 1 L bag of Custodiol (Group L), using a 10-cc syringe.
干预措施: Lidocaine Hydrochloride (Drug)
Custodiol group
standard Custodiol cardioplegia solution (manufactured by Dr. Franz Köhler Chemie GmbH, Bensheim, Germany), punctured at the injection port with a 10-cc syringe for blinding
干预措施: Custodiol Solution (Drug)
Lidocaine and Custodiol group
the modified solution prepared by adding 6.5 ml of 2% lidocaine (Lidocaine HCL -Sunny Pharmaceutical) to each 1 L bag of Custodiol (Group L), using a 10-cc syringe.
干预措施: Custodiol Solution (Drug)
结局指标
主要结局
incidence of ventricular fibrillation (VF)
时间窗: Perioperative
incidence of VF occurring after Aorta cross-clamp (ACC) removal
次要结局
- Troponin I (µg/L)(At immediate postoperatively, 12 and 24 hours postoperative)
- Number of defibrillator shocks(Perioperative)
- Total volume of cardioplegia solution (in ml).(Perioperative)
- Total cross-clamp time(from cross clamp until removal of aorta cross clamp up to 6 hours)
- total CPB time(from starting CPB until weaning from bypass is completed up to 6 hours)
- Number of grafts(at the end of surgery up to 6 hours)
- Time taken to cardiac arrest after cardioplegia infusion(from the start of cardioplegia administration until asystole up to one hour)
- Left ventricular ejection fraction assessed both preoperative and after 24 hours postoperatively.(assessed both preoperative and after 24 hours postoperatively.)
- Preoperative EURO II score(assessed preoperatively at the start of patient enrollment)
- Inotropic support.(assessed after patient is transferred to intensive care up to 6 hours from start of surgery)
- Total time of inotropes or vasopressor requirement in hours(assessed after patient is weaned from inotropes up to one month)
- Mortality rate(assessed up to one month postoperatively)
- CK-MB (U/L) .(at immediate postoperatively, 12 and 24 hours after surgery)
- Serum lactate level(at immediate postoperatively, 12 and 24 hours after surgery.)
- Incidence of postoperative Myocardial infarction(assessed from icu admission until discharge up to one month)
- Incidence of postoperative Atrial fibrillations(assessed from icu admission until ICU discharge up to one month)
- Time for weaning from mechanical ventilation(assessed from icu admission until ventilator weaning up to one month)
- ICU length of stay(assessed from icu admission until ICU discharge up to one month)
- hospital length of stay (in days)(assessed from icu admission until home discharge up to one month)
研究者
Mohamed Hasan Ragab
Lecturer of Anesthesiology
Fayoum University Hospital