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临床试验/NCT04244435
NCT04244435Unknown早期 1 期

Consequences of Using Thoracic Epidural Analgesia for Coronary Artery Bypass Grafting

Volgograd State Medical University1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2020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
早期 1 期
发起方
入组人数
300
试验地点
1
主要终点
hospital mortality

研究概览

简要总结

Investigators plan to study the effect of thoracic epidural analgesia on postoperative parameters (complication rate, duration of hospitalization, mortality, etc.) of coronary artery bypass grafting.

详细描述

Investigators plan to conduct a comparative analysis of early postoperative complications of coronary artery bypass grafting with and without cardiopulmonary bypass in patients with independent risk factors for the development of postoperative complications (advanced age, diabetes mellitus, chronic kidney disease, obesity, chronic obstructive pulmonary disease) with various types of anesthesiology benefits (general anesthesia and thoracic epidural analgesia versus general anesthesia and opioids). Investigators predict a decrease in the risk of developing cardiac, respiratory, infectious and renal complications, a reduction in the duration of intensive care, inpatient treatment and mortality.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • coronary artery bypass grafting

排除标准

  • Absolute contraindications for the use of thoracic epidural analgesia

研究组 & 干预措施

Thoracic epidural analgesia

Experimental

CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period

干预措施: CABG (Procedure)

Thoracic epidural analgesia

Experimental

CABG and thoracic epidural analgesia will be used for perioperative analgesia postoperative period

干预措施: thoracic epidural analgesia (Drug)

Opioids

Active Comparator

CABG and opioids will be used for perioperative analgesia

干预措施: CABG (Procedure)

Opioids

Active Comparator

CABG and opioids will be used for perioperative analgesia

干预措施: analgesia of opioids (Drug)

CABG

Active Comparator

coronary artery bypass grafting with and without cardiopulmonary bypass

干预措施: CABG (Procedure)

结局指标

主要结局

hospital mortality

时间窗: 1 year

Duration of treatment in the intensive care unit

时间窗: up to 1 year

Hospitalization duration

时间窗: 1 year

次要结局

  • Complications(1 year)

研究者

发起方
Volgograd State Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Mikhail I Turovets, MD

professor

Volgograd State Medical University

研究点 (1)

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