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Cardiovascular

A non-interventional comparative study of the 20:1 combination of cafedrine/theodrenaline versus ephedrine for the treatment of intra-operative arterial hypotension: the ‘HYPOTENS’ study design and rationale

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Pages 953-961 | Received 26 Jun 2017, Accepted 29 Jan 2018, Published online: 28 Feb 2018

References

  • Hartmann B, Junger A, Klasen J, et al. The incidence and risk factors for hypotension after spinal anesthesia induction: an analysis with automated data collection. Anesth Analg 2002;94:1521-9
  • Klasen J, Junger A, Hartmann B, et al. Differing incidences of relevant hypotension with combined spinal-epidural anesthesia and spinal anesthesia. Anesth Analg 2003;96:1491-5, table of contents
  • Bijker JB. Intraoperative hypotension. Dissertation. Utrecht University Repository, 2011.
  • Jokinen J, Adametz V, Kredel M, et al. Spinal anesthesia in high-volume, low-concentration technique for Caesarean sections: retrospective analysis. Anaesthesist 2015;64:108-14
  • Kranke P, Annecke T, Bremerich DH, et al. Anesthesia in obstetrics: tried and trusted methods, current standards and new challenges. Anaesthesist 2016;65:3-16, 18–21
  • Eberhart LH, Bein B. Intraoperative hypotonie: therapie. Anasthesiol Intensivmed Notfallmed Schmerzther 2017;52:45-54
  • Sandu N, Spiriev T, Lemaitre F, et al. New molecular knowledge towards the trigemino-cardiac reflex as a cerebral oxygen-conserving reflex. Sci World J 2010;10:811-17
  • Meuwly C, Chowdhury T, Sandu N, et al. Anesthetic influence on occurrence and treatment of the trigemino-cardiac reflex: a systematic literature review. Medicine (Baltimore) 2015;94:e807
  • Bijker JB, van Klei WA, Vergouwe Y, et al. Intraoperative hypotension and 1-year mortality after noncardiac surgery. Anesthesiology 2009;111:1217-26
  • Monk TG, Bronsert MR, Henderson WG, et al. Association between intraoperative hypotension and hypertension and 30-day postoperative mortality in noncardiac surgery. Anesthesiology 2015;123:307-19
  • Clemens KE, Quednau I, Heller AR, et al. Impact of cafedrine/theodrenaline (Akrinor(R)) on therapy of maternal hypotension during spinal anesthesia for Cesarean delivery: a retrospective study [Comparative Study Research Support, Non-U.S. Gov’t]. Minerva Ginecol 2010;62:515-24
  • Walsh M, Devereaux PJ, Garg AX, et al. Relationship between intraoperative mean arterial pressure and clinical outcomes after noncardiac surgery: toward an empirical definition of hypotension [Research Support, Non-U.S. Gov’t]. Anesthesiology. 2013;119:507-15
  • Lienhart A, Auroy Y, Pequignot F, et al. Survey of anesthesia-related mortality in France. Anesthesiology 2006;105:1087-97
  • Devereaux PJ, Yang H, Yusuf S, et al. Effects of extended-release metoprolol succinate in patients undergoing non-cardiac surgery (POISE trial): a randomised controlled trial. Lancet 2008;371:1839-47
  • Onuigbo MA, Agbasi N. Intraoperative hypotension - a neglected causative factor in hospital-acquired acute kidney injury; a Mayo Clinic Health System experience revisited. J Renal Inj Prev 2015;4:61-7
  • Sun LY, Wijeysundera DN, Tait GA, et al. Association of intraoperative hypotension with acute kidney injury after elective noncardiac surgery. Anesthesiology 2015;123:515-23
  • Hirsch J, DePalma G, Tsai TT, et al. Impact of intraoperative hypotension and blood pressure fluctuations on early postoperative delirium after non-cardiac surgery. Br J Anaesth 2015;115:418-26
  • Mets B. Should norepinephrine, rather than phenylephrine, be considered the primary vasopressor in anesthetic practice? Anesth Analg 2016;122:1707-14
  • Koch T, Knoth H. Akrinor-Injektionslösung: Ein klinisch relevantes Präparat bleibt verkehrsfähig! Pharmakologische Aspekte und klinische Einsatzgebiete [Akrinor - a clinically relevant drug remains on the market - Pharmacological aspects and clinical applications]. Anästh Intensivmed 2006;47:356-61
  • ratiopharm GmbH. Fachinformation/SmPC Akrinor. September 2016
  • Heller A, Radke J, Koch T. Proof of efficacy and dose-response relationship of Akrinor® in patients during general and regional anaesthesia. Anästh Intensivmed 2008;49:308-17
  • DGAI. Durchführung von Analgesie- und Anästhesieverfahren in der Geburtshilfe [2. überarbeitete Empfehlungen der Deutschen Gesellschaft für Anästhesiologie und Intensivmedizin und des Berufsverbandes Deutscher Anästhesisten in Zusammen arbeit mit der Deutschen Gesellschaft für Gynäkologie und Geburtshilfe]. Anästhesiologie Intensivmedizin 2009;50:S490-S495
  • Sternitzke N, Schieffer H, Rettig G, et al. Die Beeinflussung der Herz-Kreislauf-Dynamik durch die Theophyllin-Verbindung Cafedrin und Theodrenalin sowie durch ihre Kombination. Herz Kreislauf 1984;8:401-12
  • Muller H, Brahler A, Borner U, et al. Hemodynamic effects following bolus administration of different vasopressive agents for blood pressure stabilization during peridural anesthesia [English Abstract]. Regional-Anaesthesie 1985;8:43-9
  • Fischer F, Weis KH. Experimental circulatory tests and clinical experiences with 2 theophylline derivatives. Der Anaesthesist 1965;14:147-53
  • Schieffer H, Heinz H, Sternitzke N, et al. Effect of Akrinor on the cardiac and circulatory dynamics as well as on pulmonary circulation in patients with and without heart diseases. Verh Dtsch Ges Inn Med 1971;77:948-52
  • Sternitzke N, Schieffer H, Bette L. [Effect of Akrinor on cardiovascular-dynamics before and after blockade of adrenergic beta-receptors by propranolol]. Z Kardiol 1975;64:419-30
  • Bein B, Christ T, Eberhart LH. Cafedrine/theodrenaline (20:1) is an established alternative for the management of arterial hypotension in Germany-a review based on a systematic literature search [Review]. Front Pharmacol 2017;8:68
  • Veeser M, Hofmann T, Roth R, et al. Vasopressors for the management of hypotension after spinal anesthesia for elective caesarean section. Systematic review and cumulative meta-analysis. Acta Anaesthesiol Scand 2012;56:810-16
  • Bangash MN, Kong ML, Pearse RM. Use of inotropes and vasopressor agents in critically ill patients. Br J Pharmacol 2012;165:2015-33
  • Sintetica GmbH. Fachinformation/SMPC Ephedrine Meduna. 2014
  • Brunton L, Chabner B, Knollman B. Goodman and Gilman’ The pharmacological basis of therapeutics. 12 ed. New York City, USA: McGraw-Hill Education; 2011
  • BfARM. Empfehlungen des Bundesinstituts für Arzneimittel und Medizinprodukte und des Paul-Ehlrich-Instituts zur Planung, Bonn, Germany Durchführung udn Auswertung von Anwendungsbeobachtungen. 2010
  • Heller AR, Heger J, Gama de Abreu M, et al. Cafedrine/theodrenaline in anaesthesia: influencing factors in restoring arterial blood pressure. Anaesthesist 2015;64:190-6
  • Bijker JB, van Klei WA, Kappen TH, et al. Incidence of intraoperative hypotension as a function of the chosen definition: literature definitions applied to a retrospective cohort using automated data collection. Anesthesiology 2007;107:213-20
  • Klohr S, Roth R, Hofmann T, et al. Definitions of hypotension after spinal anaesthesia for caesarean section: literature search and application to parturients. Acta Anaesthesiol Scand 2010;54:909-21
  • Lütz A, Radtke FM, Franck M, et al. [The Nursing Delirium Screening Scale (NU-DESC)] [evaluation studies]. Anasthesiol Intensivmed Notfallmed Schmerzther 2008;43:98-102
  • Kerry SM, Bland JM. The intracluster correlation coefficient in cluster randomisation. BMJ 1998;316:1455
  • Marcus HE, Behrend A, Schier R, et al. Anesthesiological management of Caesarean sections: nationwide survey in Germany [Review]. Der Anaesthesist 2011;60:916-28
  • Sintetica GmbH. Fachinformation/SMPC Phenylephrine Sintetica. Aschaffenburg, Germany 2015
  • Gossop M, Keaney F, Sharma P, et al. The unique role of diamorphine in British medical practice: a survey of general practitioners and hospital doctors. Eur Addict Res 2005;11:76-82
  • Sebastian H. Piritramide versus oxycodone for patient-controlled intravenous analgesia. Opioid-induced side effects [journal article]. Schmerz 2014;28:614-21
  • Benson K, Hartz AJ. A comparison of observational studies and randomized, controlled trials. N Engl J Med 2000;342:1878-86
  • Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:1887-92

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