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临床试验/NCT06757868
NCT06757868已完成不适用

The Effect of Amobarbital on Myocardial Protection and Prognosis in Patients Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Tongji Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2025年2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
已完成
入组人数
80
试验地点
1
主要终点
Cardiac recurrence time

研究概览

简要总结

Explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.

详细描述

AMO is a short acting complex I blocker that blocks mitochondrial complex I between flavoprotein and ubiquitin, and its blocking effect can be rapidly reversed. Our study is to explore the effects of amobarbital on myocardial protection and prognosis in patients undergoing cardiac surgery with cardiopulmonary bypass, investigate the new usage of old drugs, and provide reliable clinical scientific basis for its potential value in better clinical treatment.

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
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Age range: 18-65 years old, undergo elective cardiac surgery with extracorporeal circulation.
  • •ASA II-III;
  • •surgical duration is 3-6 hours;
  • •Sign the informed consent form

排除标准

  • •BMI less than 18 kg/m2 or greater than 30 kg/m2;
  • •Individuals with a history or potential history of drug abuse or alcohol dependence;
  • •Preoperative use of sedatives or analgesics;
  • •Individuals with severe liver and kidney dysfunction;
  • •Individuals who are allergic or potentially allergic to barbiturates;
  • •Patients with coagulation dysfunction, endocrine disorders, or other conditions that affect hemodynamic status;
  • •Participated in other clinical studies in the past 3 months;
  • •The researchers believe that participants who are not suitable to participate in this study.

研究组 & 干预措施

Amo group

Experimental

amobarbital 1mg/kg is given prior to cardiopulmonary bypass

干预措施: Amobarbital (Drug)

Mida group

Active Comparator

midazolam 0.1mg/kg is given prior to cardiopulmonary bypass

干预措施: Midazolam (Drug)

结局指标

主要结局

Cardiac recurrence time

时间窗: 1 hour after heart beat recurrence

Stop extracorporeal circulation until heart beat time

次要结局

  • extubation time(1day)
  • cTnI(2 days)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

aijun xu

Doctor

Tongji Hospital

研究点 (1)

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