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临床试验/DRKS00028589
DRKS00028589已完成3 期

A Randomized Open Label, Parallel Group Study to Evaluate the Hemodynamic Effects of Cafedrine/Theodrenaline vs Noradrenaline in the Treatment of Intraoperative Arterial Hypotension in Adults after Induction of General Anesthesia. - HERO-trial

TEVA-ratiopharm GmbH Medical Affairs0 个研究点目标入组 223 人开始时间: 2022年4月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
223

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized controlled study
盲法
Open (masking not used)

入排标准

年龄范围
50 Years 至 one(—)
性别
All

入选标准

  • undergoing elective vascular surgery
  • require arterial cannulation
  • require advanced hemodynamic monitoring prior to induction of general anesthesia
  • require antihypotensive drug treatment due to arterial hypotension

排除标准

  • a. The patient has a known hypersensitivity to any components of the IMPs stated in this protocol;
  • b. The patient has a known hypersensitivity to sodium metabisulfite;
  • c. The patient has bronchial asthma with sulfite hypersensitivity;
  • d. The patient has diagnosis of clinical relevant mitral stenosis;
  • e. The patient has diagnosis of clinical relevant aortic stenosis;
  • f. The patient has a diagnosis of hyperthyroidism;
  • g. The patient has a diagnosis of pheochromocytoma;
  • h. The patient is going to receive any cardiac sensitizing agent (e.g. cyclopropane or halothane) or is going to have deep hypoxia or hypercapnia concomitant to application of IMP;
  • i. The patient has uncontrolled hypertension as co-morbidity;
  • j. The patient has sepsis, septic shock, or systemic inflammatory response syndrome (SIRS)

研究者

发起方
TEVA-ratiopharm GmbH Medical Affairs

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