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- Peter Kranke, Götz Geldner, Peter Kienbaum, Hans Jürgen Gerbershagen, Daniel Chappell, Jan Wallenborn, Susanne Huljic, Tilo Koch, Thomas Keller, Stephan Weber, Oliver Kunitz, Ulf Linstedt, EberhartLeopold H JLHJ, and HYPOTENS study group.
- From the Department of Anaesthesiology, Intensive Care, Emergency and Pain Medicine, University Hospital Würzburg, Würzburg (PK), the Clinic for Intensive Care, Emergency Medicine and Pain Therapy, Hospital Ludwigsburg, Ludwigsburg (GG), the Department of Anaesthesiology, University Hospital Düsseldorf, Düsseldorf (PK), the Department of Anaesthesiology, Surgical Intensive Care, Emergency Medicine and Pain Management, Marienhospital Gelsenkirchen, Gelsenkirchen (HJG), the Department of Anaesthesiology and Intensive Care Medicine, Klinikum Frankfurt Höchst, Frankfurt (DC), the Department of Anaesthesiology and Intensive Care, HELIOS Clinic Aue, Aue (JW), ratiopharm GmbH, Ulm (SH), the Department of Anaesthesiology & Intensive Care, Philipps University Marburg, Marburg (TK, LHJE), ACOMED Statistik, Leipzig (TK, SW), the Department of Anaesthesia, Emergency and Intensive Care Medicine, Klinikum Mutterhaus der Borromäerinnen gGmbH, Trier (OK), the Department of Anaesthesiology, Intensive Care Medicine and Pain Therapy, Diako Hospital, Flensburg, Germany (UL) on behalf of the HYPOTENS study group.
- Eur J Anaesthesiol. 2021 Oct 1; 38 (10): 106710761067-1076.
BackgroundIn Germany, hypotension induced by spinal anaesthesia is commonly treated with a combination of cafedrine hydrochloride (C, 200 mg) and theodrenaline hydrochloride (T, 10 mg) in 2 ml. We compared the effectiveness of C/T with ephedrine.ObjectivesThe primary objectives were to assess the speed of onset and the ability to restore blood pressure without an increase in heart rate. Secondary objectives were to evaluate maternal/foetal outcomes and the number of required additional boluses or other additional measures.DesignHYPOTENS was a national, multicentre, prospective, open-label, two-armed, noninterventional study comparing C/T with ephedrine in two prospectively defined cohorts. This study relates to the cohort of patients receiving spinal anaesthesia for caesarean section.SettingGerman hospitals using either C/T or ephedrine in their routine clinical practice.PatientsWomen aged at least 18 years receiving spinal anaesthesia for caesarean section.InterventionsBolus administration of C/T or ephedrine at the discretion of the attending anaesthesiologist.Main Outcome MeasuresEndpoints within 15 min after initial administration of C/T or ephedrine were area under the curve between the observed SBP and the minimum target SBP; and incidence of newly occurring heart rate of at least 100 beats min-1.ResultsAlthough effective blood pressure stabilisation was achieved with both treatments, this effect was faster and more pronounced with C/T (P < 0.0001). The incidence of tachycardia and changes in heart rate were higher with ephedrine (P < 0.01). Fewer additional boluses (P < 0.01) were required with C/T. Although favourable neonatal outcomes were reported in both groups, base deficit and lactate values were greater with ephedrine (P < 0.01). Physician satisfaction was higher with C/T.ConclusionsAfter C/T, tachycardia was not a problem, providing an advantage over ephedrine. Fewer additional boluses were required with C/T, suggesting greater effectiveness. An increased base deficit with ephedrine suggests reduced oxygen supply or increased demands in foetal circulation.Trials RegistrationClinicaltrials.gov: NCT02893241, German Clinical Trials Register: DRKS00010740.Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc. on behalf of the European Society of Anaesthesiology.
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