Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting
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ClinicalTrials.gov Identifier: NCT02893241 |
Recruitment Status :
Completed
First Posted : September 8, 2016
Last Update Posted : November 9, 2021
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Condition or disease | Intervention/treatment |
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Hypotension | Drug: Cafedrine/theodrenaline Drug: Ephedrine |
Study Type : | Observational |
Actual Enrollment : | 2013 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting: a Multicenter, Prospective, Non-interventional Study |
Actual Study Start Date : | April 30, 2016 |
Actual Primary Completion Date : | December 31, 2017 |
Actual Study Completion Date : | December 31, 2017 |

Group/Cohort | Intervention/treatment |
---|---|
Cohort A
Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia
|
Drug: Cafedrine/theodrenaline Drug: Ephedrine |
Cohort B
Patients, who undergo caesarean section under spinal anaesthesia
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Drug: Cafedrine/theodrenaline Drug: Ephedrine |
- The incidence of newly occurring HR ≥ 100 beats/min [ Time Frame: 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 [ Time Frame: 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 ]

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Ages Eligible for Study: | 18 Years to 50 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02893241

Study Director: | Teva Medical Expert, MD | Teva Branded Pharmaceutical Products R&D, Inc. |
Responsible Party: | Ratiopharm GmbH |
ClinicalTrials.gov Identifier: | NCT02893241 |
Other Study ID Numbers: |
TV48531-CV-40092 |
First Posted: | September 8, 2016 Key Record Dates |
Last Update Posted: | November 9, 2021 |
Last Verified: | November 2021 |
Hypotension Vascular Diseases Cardiovascular Diseases Cafedrine Theodrenaline Ephedrine Central Nervous System Stimulants Physiological Effects of Drugs Sympathomimetics |
Autonomic Agents Peripheral Nervous System Agents Vasoconstrictor Agents Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Antihypertensive Agents Vasodilator Agents |