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

Ratiopharm

Status: Completed

Conditions: Hypotension

Treatments: Drug: Cafedrine/theodrenaline; Drug: Ephedrine

Study type: Observational

Funder types: Industry

Identifiers

NCT02893241

TV48531-CV-40092

Details and patient eligibility

About

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.

Enrollment: 2,013 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

2,013 participants in 2 patient groups

Cohort A

Description:

Patients ≥ 50 years old, with pre-existing comorbidities, who receive general anaesthesia

Treatment:

Drug: Cafedrine/theodrenaline

Drug: Ephedrine

Cohort B

Description:

Patients, who undergo caesarean section under spinal anaesthesia

Treatment:

Drug: Cafedrine/theodrenaline

Drug: Ephedrine