Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting

Conditions

Hypotension

Brief summary

This is a national, multicentre, prospective, open, two-arm, non-interventional study with hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine after occurrence of perioperative hypotension, wherein the patients are assigned to a treatment arm based on the department.

Christiane Dings, Thorsten Lehr, Benjamin Vojnar, Christine Gaik, T. Koch et al. (9 authors)

British Journal of Clinical Pharmacology2024-05-094 citations

10.1111/bcp.16083

Treatment of spinal anaesthesia-induced hypotension with cafedrine/theodrenaline versus ephedrine during caesarean section

Peter Kranke, Götz Geldner, Peter Kienbaum, H. U. Gerbershagen, Daniel Chappell et al. (13 authors)

European Journal of Anaesthesiology2021-02-2015 citations

10.1097/eja.0000000000001474

Treatment of intraoperative hypotension with cafedrine/theodrenaline versus ephedrine : A prospective, national, multicenter, non-interventional study-the HYPOTENS trial.

Eberhart L, Geldner G, Kowark A, Zucker TP, Kreuer S, Przemeck M, Huljic S, Koch T, Keller T, Weber S, Kranke P, HYPOTENS study group.

2020-11-102 citations

10.1007/s00101-020-00877-5

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

Leopold Eberhart, Götz Geldner, Susanne Huljic, Kerstin Marggraf, Thomas Keller et al. (7 authors)

Current Medical Research and Opinion2018-02-086 citations

10.1080/03007995.2018.1438379

Interventions

DRUGCafedrine/theodrenaline

DRUGEphedrine

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

No

Inclusion criteria

* Inpatients, who received IV treatment (bolus administration) with cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) due to an acute arterial hypotension * Consent to use of data is available * Patient under careful blood pressure and pulse monitoring (at least 2 minutes measuring interval (BP/HR) and/or at least 7 measurements within the first 15 minutes after the first application of cafedrine/theodrenaline or ephedrine) Cohort A: * Treatment of hypotension in \< 100 mm Hg syst. and/or drop in blood pressure \> 20% syst. compared to preoperative base value (syst.) * Patients ≥ 50 years old * Pre-existing comorbidities (ASA classification 2-4) * Elective surgery * General anaesthesia with propofol/fentanyl ≥ 0.2 mg (or equivalent) Cohort B: * Treatment of hypotension in \< 100 mm Hg syst. and/or drop in blood pressure \> 10% syst. compared to preoperative base value (syst.) * Patients ≥ 18 years old * Caesarean section under spinal anaesthesia

Exclusion criteria

* Contraindication to the use of cafedrine/theodrenaline or ephedrine (Ephedrin Meduna) in accordance with current German specialist information * Hypersensitivity to any product ingredient * Hypertensive blood pressure readings * Mitral stenosis * Narrow-angle glaucoma * Hyperthyroidism * Pheochromocytoma * Prostatic adenoma with urinary retention * Bronchial asthmatics with sulphite sensitivity * Hyper-excitability * Arteriosclerosis * Aneurysm * Treatment with other indirect sympathomimetic drugs (Example: phenylpropanolamine, phenylephrine, pseudoephedrine or methylphenidate) * Use of Monoamine oxidase (MAO) inhibitors (including within the last two weeks) * Prophylactic administration of cafedrine/theodrenaline or ephedrine or other anti-hypertensives * Sepsis, septic shock or systemic inflammatory response syndrome (SIRS) Cohort A: • Intra-cranial surgery or heart surgery Cohort B: * High-risk pregnancy (emergency Caesarean, severe infantile malformation) * Multiple pregnancy * Amniotic infection syndrome

Design outcomes

Primary

Measure	Time frame
The incidence of newly occurring HR ≥ 100 beats/min	during the first 15 minutes after initial drug administration of cafedrine/theodrenaline or ephedrine
Weighted deviation below the individually determined, lowest systolic blood pressure BPmin	within the first 15 minutes after the initial delivery of the antihypotonic drug as area1 (AUC) between the systolic blood pressure curve (below BPmin) and the lower limit BPmin

Countries

Germany

Outcome results

None listed