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临床试验/NCT05502211
NCT05502211招募中不适用

A Comparison Between Ketamine-lidocaine Versus Ketamine-fentanyl for Induction on the Hemodynamic Effects in Patients With Coronary Artery Disease and Left Ventricular Systolic Dysfunction :( A Randomized Controlled Study

Kasr El Aini Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年11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
状态
招募中
发起方
入组人数
100
试验地点
2
主要终点
incidence of hypotension

研究概览

简要总结

Patients with coronary artery disease (CAD) and left ventricular systolic dysfunction (LVSD) presenting for coronary artery bypass grafting (CABG) represent a high-risk group among the cardiac surgical population. Anesthetic management of these patients is challenging due to increased risk of perioperative hypotension and subsequently increased risk of postoperative morbidity and mortality. Post induction hypotension is a modifiable risk that can be largely prevented by adjusting the technique for anesthesia induction. There is no consensus on the use of certain anesthetic induction techniques for patients CAD and left ventricular dysfunction. Anesthesia induction techniques for cardiovascular surgery are usually based on considerations such as hemodynamic stability, effects on myocardial oxygen supply, and demand and minimizing intubation stress response.To the best of our knowledge, there is no previous data comparing the efficacy of adding lidocaine versus fentanyl to the induction of anesthesia with ketamine in patients with poor ventricular function.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participants will be patients with coronary artery disease and moderate to severe left ventricular dysfunction (ejection fraction < 40%), ASA physical status II-IV that will be scheduled for elective CABG surgery.

排除标准

  • Patients with associated valvular heart disease, persistent arrhythmias, congestive cardiac failure, on mechanical ventilation, intra-aortic balloon pump (IABP), emergency surgery, and those with known allergy to any of the study's drugs, severe systemic non-cardiac disease; will be excluded from the study

研究组 & 干预措施

Lidocaine

Experimental

干预措施: Lidocaine IV (Drug)

Fentanyl

Active Comparator

干预措施: Fentanyl (Drug)

结局指标

主要结局

incidence of hypotension

时间窗: 15 minutes post inductin

the number of patients who will develop hypotension

次要结局

未报告次要终点

研究者

发起方
Kasr El Aini Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ayman Abougabal

Dr Abougabal

Kasr El Aini Hospital

研究点 (2)

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