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临床试验/NCT06496165
NCT06496165尚未招募不适用

Comparison of the Effects of Remimazolam Besylate and Propofol Sedation on Hemodynamic for Coronary Artery Bypass Graft Patients:a Prospective, Single Blinded, Randomized Controlled Trial

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 338 人开始时间: 2024年7月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
338
试验地点
1
主要终点
rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery

研究概览

简要总结

In the immediate postoperative period following cardiac surgery, many patients require short-term sedation until cardiovascular and respiratory stability has been achieved and weaning from artificial ventilation can be started. For these patients, current guideline recommended propofol over benzodiazepine, mainly because of the short elimination half life of propofol. However, hypotension, a very common side effect of propofol, may impose restrictions on its use in some cardiac surgery patients. Remimazolam besylate is a novel, ultra-short-acting benzodiazepine that undergoes organ-independent metabolism by tissue esterases into an inactive metabolite. In other words, remimazolam has both the property of quick offset of effect like propofol and the stable hemodynamic effect like midazolam, making it favorable for use as a sedative in cardiac surgery patients. The aim of this study is to evaluate the hemodynamic effect of remimazolam besylate versus propofol in patients undergoing 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
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • Sign the informed consent form voluntarily and follow the plan requirements;
  • age over 60 years old;
  • post coronary artery bypass surgery;
  • anticipated mechanical ventilation duration >8 hours
  • admission to the cardiac surgery intensive care unit of Zhongshan hospital, Fudan University

排除标准

  • delirium before surgery
  • severe cognitive dysfunction before surgery
  • patients with over degree II A-V block or consistent bradycardia
  • patients who are still not awake 12 hours after surgery
  • patients who are agitated or cannot follow command
  • patients with mechanical circulatory support (ECMO, IABP)
  • patients who are allergy to propofol or remimazolam
  • BMI≥30kg/m2
  • patients with much drainage, the surgery ask for blood pressure control or reopen the chest

研究组 & 干预措施

remimazolam

Experimental

干预措施: Remimazolam (Drug)

propofol

Active Comparator

干预措施: Propofol (Drug)

结局指标

主要结局

rate of hypotension during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery

时间窗: Within 8 hours of study drug used

次要结局

  • RASS score during infusion of remimazolam or propofol in patients undergoing coronary artery bypass surgery(Within 8 hours of study drug used)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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