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临床试验/NCT05218161
NCT05218161Unknown不适用

Comparing the Hemodynamic Effect of Dexmedetomidine Alone With Dexmedetomidine Plus Ketamine Combination in Post Cardiac Surgery Patients: A Randomized Controlled Trial

Chaudhry Pervaiz Elahi Institute of Cardiology1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2021年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
40
试验地点
1
主要终点
Hemodynamic stability

研究概览

简要总结

In post cardiac surgery, many cardiovascular and other complications may occur that lead to increase in mortality and hospital stays. Meticulous perioperative management is important to avoid these adverse events. Tachycardia is the main cause of post coronary artery bypass graft (CABG) myocardial ischemia which can be decreased by sedation and analgesia.

详细描述

Dexmedetomidine is a highly specific alpha 2 adrenoreceptor agonist. Its sedative effect results from stimulation of alpha 2 adrenoreceptors in the central nervous system (in the locus coeruleus) independent of GABA system contrary to other drugs.Dexmedetomidine has better sedative effect and similar respiratory and hemodynamic effects to midazolam. It does not depress respiratory drive or decrease arterial oxygen saturation so intravenous (IV) continuous sedation with dexmedetomidine does not change the normal course of ventilator weaning and extubation. It produces a unique EEG pattern of sleep that closely resembles that of normal physiological sleep that allows easy arousal. Dexmedetomidine also has analgesic effect. All these properties make dexmedetomidine a first line drug for the cooperative sedation management in the Intensive Care Unit (ICU). Ketamine is a phencyclidine nonbarbiturate derivative that binds with N methyl d aspartate and sigma opioid receptors to produce dissociative anesthesia, analgesia, and amnesia with little or no respiratory or cardiovascular depression. Ketamine inhibits endothelial nitric oxide production leading to positive inotropic action and vasoconstriction which preserves hemodynamic stability. Dexmedetomidine can effectively and safely attenuate the ketamine induced hemodynamic pressor response and psychomimetic effects. Dexmedetomidine expected to prevent the tachycardia, hypertension, salivation, and emergence phenomena associated with ketamine. Ketamine may prevent the bradycardia and hypotension that have been reported with dexmedetomidine. Review of literature has shown that there are very few studies present on the comparison of combination of Ketamine and dexmedetomidine with dexmedetomidine alone especially in post cardiac surgery patients and therefore further studies are required to ascertain the role of dexmedetomidine in terms of hemodynamic effects after cardiac surgery.

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)

入排标准

年龄范围
20 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients of 40-60 years old Hemodynamically stable with normal or moderately impaired left ventricular function Ejection fraction >40% that underwent elective surgery CABG surgery for single vessel

排除标准

  • Hemodynamic instability intraoperative. Patients on moderate to high vasopressors or ionotropes. Ejection fraction less than 40%. Off pump surgery. Patient on mechanical supports.

研究组 & 干预措施

DA

Active Comparator

Group DA: will be assigned to patients in whom dexmedetomidine alone will be used.

干预措施: Dexmedetomidine alone (Drug)

KD

Experimental

Group KD: will be assigned to patients receiving ketamine plus dexmedetomidine.

干预措施: Dexmedetomidine alone (Drug)

结局指标

主要结局

Hemodynamic stability

时间窗: 06 months

Hemodynamic stability:If blood pressure and heart rate are with in appropriate limits,it will be considered as hemodynamically stable. Blood pressure:MAP\>65 mmhg is considered stable. Heart rate:80-100 bpm is considered stable.

次要结局

未报告次要终点

研究者

发起方
Chaudhry Pervaiz Elahi Institute of Cardiology
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Shumaila rai

Consultant anesthetist

Chaudhry Pervaiz Elahi Institute of Cardiology

研究点 (1)

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