A Comparative Study Between Dexmedetomidine Versus Methylprednisolone on Induced Inflammatory Response in Patients Undergoing On-pump CABG
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Induced inflammatory response
研究概览
简要总结
A comparison between precedex versus solumedrol as anti-inflammatory stress response inhibitors in patients undergoing on-pump CABG using different inflammatroy response parameters and the outcome of the drugs on the cognitive and cardiac status post extubation
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Randomized Double blinded clinical trial
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 21-60 years.
- •Sex: Both sexes.
- •American Society of Anaesthesiologists (ASA) Physical Status Class II, and III.
- •Scheduled for CABG on cardio-pulmonary bypass.
排除标准
- •Declining to give a written informed consent.
- •History of allergy to the medications used in the study.
- •Psychiatric disorders.
- •Significant cognitive dysfunction.
- •American Society of Anesthesiologists (ASA) Physical Status Class IV.
- •Chronic liver or kidney disease.
- •Poor systolic function ( Ejection fraction < 40% ).
- •9.Infection during the week preceding surgery white blood cell count over 11,000 mm3 10.Pre-operative use of antibiotics or corticosteroids.
研究组 & 干预措施
Control
Control group receiving 10 ml of normal saline after induction of anesthesia then followed by infusion of normal saline till extubation in ICU
干预措施: Normal saline (Drug)
Dexmedetomidine
Starting with precedex loading dose after anesthesia induction then infusion till extubation in ICU
干预措施: Dexmedetomidine (Drug)
Methylprednisolone
To be diluted in 10 ml normal saline then given after induction of anesthesia then followed by normal saline infusion till extubation in ICU
干预措施: Methylprednisolone (Drug)
结局指标
主要结局
Induced inflammatory response
时间窗: First 24 hours post cardio-pulmonary bypass
Effect of both drugs on attenuating induced inflammatory response
次要结局
- Cognitive function(First 24 hours post cardio-pulmonary bypass)