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

• Status: Completed
• Trial end date: 2017-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ratiopharm GmbH
• Treatments: Cafedrine; Ephedrine; Pseudoephedrine; Theodrenaline; Theophylline

Criteria

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