Akrinor® versus Ephedrine for treatment of hypotension in the peri-operative phase in inpatient setting: a multicenter, prospective, non-interventional study - HYPOTENS

ratiopharm GmbH0 个研究点目标入组 1,673 人开始时间: 2016年7月4日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Inpatients requiring IV treatment with Cafedrine/Theodrenaline or Ephedrine (Sintetica) during surgical interventions due to acute arterial hypotension with signed informed consent form and treated according to the SmPC
•Inpatients with tight blood pressure monitoring and pulse measurement (at least interval of 2 minutes and/or at least 7 measurements up to 15 minutes after first application of Cafedrine/Theodrenaline or Ephedrine)
•Male of female inpatients undergoing non-emergency surgery under general anaesthesia) with systolic blood pressure (SBP) < 100 mmHg and / or ? 20 % drop (SBP) compared to preoperative baseline value who are 50 years or older, have pre-existing morbidity (defined as an ASA-classification of 2-4), receiving anaesthesia induction with propofol and fentanyl (= 0.2 mg) (or equivalent) as the main induction agents
•parturients undergoing non-emergency cesarean section under spinal anaesthesia presenting with SBP < 100 mmHg and / or ? 10 % drop (SBP) compared to preoperative baseline value, 18 years or older

•patients who have any of the contraindication for the use of Cafedrine/Theodrenaline or Ephedrine Meduna (Sintetica) according to the current German SmPC
•patients undergoing prophylactic treatment with Cafedrine/Theodrenaline or Ephedrine or other antihypotensive drugs
•any signs of sepsis, septic shock or systemic inflammation response syndrome (SIRS)
•intracranial or cardiac surgery
•only for parturients undergoing cesarean section in spinal anaesthesia:
•- high-risk pregnancy
•- multigravida parturients
•- amnion infection syndrome

发起方