Refocusing On Morphine: Myocardial Protection Versus Fentanyl Via Pharmacological Conditioning In Acyanotic Pediatric Cardiac Surgery - A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- comparison of myocardial protection
研究概览
简要总结
This study compared two opioid pain medications - morphine and fentanyl - used during open-heart surgery in young children born with heart defects (congenital heart disease).
During open-heart surgery, the heart is temporarily stopped to allow surgeons to repair the defect. This process can cause damage to the heart muscle due to reduced blood flow and its restoration, known as ischemia-reperfusion injury, which is one of the leading causes of complications in children undergoing heart surgery.
Morphine is known to activate specific receptors in the heart that may help protect it against this type of injury - a process called pharmacological preconditioning. While fentanyl has largely replaced morphine in pediatric cardiac anesthesia over the years, emerging evidence suggests that morphine may have unique heart-protective properties that fentanyl lacks.
The purpose of this study was to investigate whether morphine provides better heart muscle protection than fentanyl in children with non-cyanotic congenital heart disease undergoing elective open-heart surgery. The study also aimed to compare postoperative recovery, need for heart-supporting medications, and other clinical outcomes between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Due to the differing dosing regimens and administration routes of the two opioids, and the need for precise weight-based dose titration in pediatric patients, blinding of the care provider and investigator was not feasible. However, the paediatric cardiologists performing echocardiographic assessments, the laboratory personnel analysing blood biomarker levels, and the investigators assessing postoperative outcomes were blinded to group allocation.
入排标准
- 年龄范围
- 1 Year 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acyanotic children
- •aged 1-6 years
- •scheduled for elective congenital open-heart surgery requiring cardiopulmonary bypass
排除标准
- •reoperative surgery,
- •preoperative hemodynamic instability or inotropic support
- •history of myocarditis, renal failure, congestive heart failure, hypertrophic cardiomyopathy, severe pulmonary disease requiring mechanical ventilation, pulmonary embolism, hypothyroidism, familial muscle disease
- •known allergy to morphine or fentanyl
- •prior cardioversion or cardiopulmonary resuscitation
- •cyanotic heart disease
- •age outside the 1-6 year range.
研究组 & 干预措施
Group morphine
Patients received morphine 0.15 mg/kg intravenously at anesthesia induction, followed by 0.15 mg/kg before skin incision, with maintenance via continuous infusion at 0.1 mg/kg/h throughout surgery.
干预措施: morphine (Drug)
Group fentanyl
Patients received fentanyl 1.5 µg/kg intravenously at anesthesia induction, followed by 1.5 µg/kg before skin incision, with maintenance via continuous infusion at 1 µg/kg/h throughout surgery.
干预措施: Fentanyl (IV) (Drug)
结局指标
主要结局
comparison of myocardial protection
时间窗: -Venous blood samples were collected at three time points: before skin incision (malondialdehyde1), at the end of surgery (malondialdehyde2), 6 hour postoperatively (malondialdehyde3)
-plasma malondialdehyde (ng/ml) levels
comparison of myocardial protection
时间窗: Venous blood samples were collected at three time points: before skin incision (glutathione1), at the end of surgery (glutathione2), and 6 h postoperatively (glutathione3)
plasma glutathione (ng/ml) levels
comparison of myocardial protection
时间窗: Transthoracic echocardiography (TTE) was performed before skin incision and at 6 hours postoperatively
echocardiographic parameters (left ventricular end-diastolic and end-systolic Z scores and EF (%))
次要结局
- secondary outcome(perioperatively)
- secondary outcome(from end of the surgery up to extubation)
- Secondary Outcome(periprocedurally)
- Secondary Outcome(perioperatively)
- Secondary Outcome(from surgery up to 30 days postoperatively)