A RANDOMISED COMPARATIVE STUDY FOR CARDIAC PRECONDITIONING EFFECT OF KETAMINE-DEXMEDETOMIDINE VERSUS FENTANYL-PROPOFOL IN PATIENTS UNDERGOING CARDIAC SURGERY IN THE DEPARTMENT OF ANAESTHESIA.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- To assess and compare the Plasma cardiac troponin-I, CK-MB level, serum cortisol level in Ketamine-dexmedetomidine group and fentanyl-propofol group
研究概览
简要总结
Patient arrival in OT
Wt, fasting status, written informed consent and PAC will be checked; Monitoring of patient started using pulse oximeter and ECG.
Randomisation
IV line will be secured. IJV and invasive arterial line will be secured under local anaesthesia.
After preoxygenation with 100% oxygen, induction will be done with Inj. Midazolam 0.05mg/kg,Inj. Fentanyl 4 microgram/kg, Inj. Propofol 2mg/kg and Inj. Rocuronium0.9mg/kg OR Inj. Midazolam 0.05mg/kg, Inj. Dexmedetomidine 1 microgram/kg, Inj. ketamine 2mg/kg and Inj. Rocuronium0.9mg/kg
Blood samples for cardiac biomarkers will be collected at specified time intervals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Informed written consent for the study
- •All patients will be American Society of Anaesthesiologists physical status II-III.
- •Aged between 18 and 70 years.
- •Weight between 40 and 70 kg.
- •BMI less than
- •New York Heart Association classification of cardiac function II-III,
- •Ejection fraction greater than 40%.
排除标准
- •Patient should not part of any other study.
- •Non cooperative patient.
- •Patient with history of acute myocardial infarction.
- •Elevated levels of circulating cardiac troponin
- •History of endocrine, metabolic, neurological and psychotic disorder
- •History of previous unusual response to ketamine, dexmedotomidine, fentanyl, propofol.
结局指标
主要结局
To assess and compare the Plasma cardiac troponin-I, CK-MB level, serum cortisol level in Ketamine-dexmedetomidine group and fentanyl-propofol group
时间窗: Blood samples will be drawn before induction, 4 hours after aortic cross clamping and 24 hours after aortic cross clamping.
次要结局
未报告次要终点
研究者
Dr Anjum Saiyed
SMS Medical College