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10.11.2020 | Originalien Open Access

Treatment of intraoperative hypotension with cafedrine/theodrenaline versus ephedrine

A prospective, national, multicenter, non-interventional study—the HYPOTENS trial

Zeitschrift:
Der Anaesthesist
Autoren:
Prof. Dr. L. Eberhart, G. Geldner, A. Kowark, T.-P. Zucker, S. Kreuer, M. Przemeck, S. Huljic, T. Koch, T. Keller, S. Weber, P. Kranke, the HYPOTENS study group
Wichtige Hinweise

Electronic supplementary material

The online version of this article (https://​doi.​org/​10.​1007/​s00101-020-00877-5) contains one further table and two figures. The article and additional material are available at www.​springermedizin.​de. Please enter the title of the article in the search field. You will find the additional material under “Ergänzende Inhalte” in the article.
All members of the HYPOTENS study group are listed in alphabetical order at the end of this article.

Data sharing

Qualified researchers may request access to patient-level data and related study documents, including the study protocol and the statistical analysis plan. Requests will be reviewed for scientific merit, product approval status, and conflicts of interest. Patient-level data will be deidentified and study documents will be redacted to protect the privacy of trial participants and to protect commercially confidential information. Please email USMedInfo@tevapharm.com to make your request.
In dem ursprünglichen Artikel wurde der Name des Autors R. Muellenbach aus der HYPOTENS study group zunächst falsch geschrieben. Der Originalbeitrag wurde korrigiert.
An erratum to this article is available online at https://​doi.​org/​10.​1007/​s00101-021-00932-9.

Abstract

Background

Sympathomimetic drugs are a therapeutic cornerstone for the management of hypotensive states like intraoperative hypotension (IOH). While cafedrine/theodrenaline (C/T) is widely used in Germany to restore blood pressure in patients with IOH, more research is required to compare its effectiveness with alternatives such as ephedrine (E) that are more commonly available internationally.

Methods

HYPOTENS (NCT02893241, DRKS00010740) was a prospective, national, multicenter, open-label, two-armed, non-interventional study that compared C/T with E for treatment of IOH. We describe a prospectively defined cohort of patients ≥50 years old with comorbidities undergoing general anesthesia induced with propofol and fentanyl. Primary objectives were to examine treatment precision, rapidity of onset and the ability to restore blood pressure without relevant increases in heart rate. Secondary endpoints were treatment satisfaction and the number of required additional boluses or other accompanying measures.

Results

A total of 1496 patients were included in the per protocol analysis. Overall, effective stabilization of blood pressure was achieved with both C/T and E. Post-hoc analysis showed that blood pressure increase from baseline was more pronounced with C/T. Fewer additional boluses or other accompanying measures were required in the C/T arm. The incidence of tachycardia was comparable between groups. Post-hoc analysis showed that E produced dose-dependent elevated heart rate values. By contrast, heart rate remained stable in patients treated with C/T. Physicians reported a higher level of treatment satisfaction with C/T, with a higher proportion of anesthetists rating treatment precision and rapidity of onset as good or very good when compared with E.

Conclusion

Neither drug was superior in restoring blood pressure levels; however, post-hoc analyses suggested that treatment is more goal-orientated and easier to control with C/T. Heart rate was shown to be more stable with C/T and fewer additional interventions were required to restore blood pressure, which could have contributed to the increased treatment satisfaction reported by anesthetists using C/T.

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