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

Study Overview
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Brief Summary
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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.

Official Title
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Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting: a Multicenter, Prospective, Non-interventional Study

Conditions
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Hypotension

Intervention / Treatment
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* Drug: Cafedrine/theodrenaline
* Drug: Ephedrine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort A<br>Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia | Drug: Cafedrine/theodrenaline<br> <br> Drug: Ephedrine<br> <br> |
| Cohort B<br>Patients, who undergo caesarean section under spinal anaesthesia | Drug: Cafedrine/theodrenaline<br> <br> Drug: Ephedrine<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 |