High Dose Methylprednisolone Verses Low Dose in Correction of Congenital Acynotic Heart Disease
试验速览
- 阶段
- 4 期
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- assessment of Level of IL 6 after CPB time
研究概览
简要总结
To compare the effect of low dose methylprednisolone versus high dose on inflammatory mediators' level and cardioprotective effect after CPB in correction of congenital acyanotic heart disease.
详细描述
This study is a prospective, randomized controlled trial, at Ain Shams University hospitals, Cardiovascular surgery hospital (cardiac surgery unit), Cairo, Egypt.
All patients' legal guardians will sign written informed consent before inclusion.
Randomization will be performed using a computer-generated randomization sequence.
Complete blood count, coagulation tests will be performed for all patients prior to the planned procedure. For all patients included in this study preoperative evaluation including a complete airway evaluation (mouth opening, mallampatii grading, thyromental distance, and evaluation of dentition) will be performed. Standard fasting guidelines will be checked. (Barash PG et al., 2006).
On patient's arrival to operating room, either inhalational induction by sevoflurane 4-6 % followed by an intravenous (IV) line insertion or IV induction by Ketamine 1-2 mg /kg and 0.01 mg / kg Atropine. Standard monitoring including electrocardiography (ECG), pulse oximetry (SpO2). Anesthesia technique: fentanyl 1-5 microgram/kg, will be given during mask preoxygenation with 100% oxygen, followed by non-depolarizing muscle relaxant (atracurium 0.5 mg /Kg) and then endotracheal intubation and capnography will be applied (Barash PG et al., 2006).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Year 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •We will include pediatric patients ( 1- 16) years old undergoing surgical correction for congenital acyanotic cardiac lesions needing cardiopulmonary bypass machine.
排除标准
- •Cyanotic heart disease. 2) Closed cardiac surgeries. 3) Previous cardiac surgery. 4) Patients suffering neurological illness. 5) Diabetics. 6) Emergency procedures. 7) Patients on preoperative steroid therapy. 8) Adult patients with congenital heart disease.
研究组 & 干预措施
low dose group
low dose group. Group (A) (25 patients) patients will receive 10 mg/Kg methyl prednisolone after induction before separation to (CPB).
干预措施: methyl prednisolone (Drug)
high dose group
high dose group. Group (B) (25 patients) patients will receive 30 mg/Kg methyl prednisolone after induction before separation to (CPB).
干预措施: Methyl Prednisolonate (Drug)
Placebo group
placebo group. Group (C) (control group)(25 patients) patients will receive placebo in form of normal saline.
干预措施: Placebo (Drug)
结局指标
主要结局
assessment of Level of IL 6 after CPB time
时间窗: 3 months
comparing level of IL6 in different groups after CPB
次要结局
- Less postoperative complications related to high doses of steroid represented as blood glucose level.(3 months)
研究者
maha sadek El Derh
lecturer of anesthesia
Ain Shams University