Phase
Condition
Dizzy/fainting Spells
Circulation Disorders
Vascular Diseases
Treatment
N/AClinical Study ID
Ages 18-50 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Inpatients, who received IV treatment (bolus administration) withcafedrine/theodrenaline or ephedrine (Ephedrin Meduna) due to an acute arterialhypotension
- Consent to use of data is available
- Patient under careful blood pressure and pulse monitoring (at least 2 minutesmeasuring interval (BP/HR) and/or at least 7 measurements within the first 15 minutesafter 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
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 otheranti-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
Study Design
Connect with a study center
Teva Investigational Site 133
Aachen,
GermanySite Not Available
Teva Investigational Site 122
Amberg,
GermanySite Not Available
Teva Investigational Site 106
Aue,
GermanySite Not Available
Teva Investigational Site 116
Augsburg,
GermanySite Not Available
Teva Investigational Site 165
Aurich,
GermanySite Not Available
Teva Investigational Site 110
Bad Hersfeld,
GermanySite Not Available
Teva Investigational Site 134
Bad Saarow,
GermanySite Not Available
Teva Investigational Site 174
Bad Soden,
GermanySite Not Available
Teva Investigational Site 174
Bad Soden Am Taunus,
GermanySite Not Available
Teva Investigational Site 142
Baden-Baden,
GermanySite Not Available
Teva Investigational Site 121
Brake,
GermanySite Not Available
Teva Investigational Site 154
Dillingen,
GermanySite Not Available
Teva Investigational Site 119
Dresden,
GermanySite Not Available
Teva Investigational Site 171
Düsseldorf,
GermanySite Not Available
Teva Investigational Site 111
Eichstätt,
GermanySite Not Available
Teva Investigational Site 107
Essen,
GermanySite Not Available
Teva Investigational Site 167
Flensburg,
GermanySite Not Available
Teva Investigational Site 141
Friedberg,
GermanySite Not Available
Teva Investigational Site 131
Fulda,
GermanySite Not Available
Teva Investigational Site 114
Gelnhausen,
GermanySite Not Available
Teva Investigational Site 158
Gelsenkirchen,
GermanySite Not Available
Teva Investigational Site 164
Gießen,
GermanySite Not Available
Teva Investigational Site 159
Greifswald,
GermanySite Not Available
Teva Investigational Site 149
Göppingen,
GermanySite Not Available
Teva Investigational Site 113
Hamburg,
GermanySite Not Available
Teva Investigational Site 163
Hamburg,
GermanySite Not Available
Teva Investigational Site 143
Hannover,
GermanySite Not Available
Teva Investigational Site 144
Hannover,
GermanySite Not Available
Teva Investigational Site 151
Hannover,
GermanySite Not Available
Teva Investigational Site 129
Heilbronn,
GermanySite Not Available
Teva Investigational Site 112
Herford,
GermanySite Not Available
Teva Investigational Site 160
Hildesheim,
GermanySite Not Available
Teva Investigational Site 132
Homburg,
GermanySite Not Available
Teva Investigational Site 168
Idar-Oberstein,
GermanySite Not Available
Teva Investigational Site 147
Jena,
GermanySite Not Available
Teva Investigational Site 123
Karlsruhe,
GermanySite Not Available
Teva Investigational Site 157
Kassel,
GermanySite Not Available
Teva Investigational Site 104
Kempen,
GermanySite Not Available
Teva Investigational Site 146
Köln,
GermanySite Not Available
Teva Investigational Site 117
Leipzig,
GermanySite Not Available
Teva Investigational Site 135
Leipzig,
GermanySite Not Available
Teva Investigational Site 118
Leverkusen,
GermanySite Not Available
Teva Investigational Site 102
Lingen,
GermanySite Not Available
Teva Investigational Site 109
Ludwigsburg,
GermanySite Not Available
Teva Investigational Site 139
Lüneburg,
GermanySite Not Available
Teva Investigational Site 101
Marburg,
GermanySite Not Available
Teva Investigational Site 155
Minden,
GermanySite Not Available
Teva Investigational Site 138
Mönchengladbach,
GermanySite Not Available
Teva Investigational Site 127
München,
GermanySite Not Available
Teva Investigational Site 130
Münster,
GermanySite Not Available
Teva Investigational Site 124
Neuruppin,
GermanySite Not Available
Teva Investigational Site 152
Nürnberg,
GermanySite Not Available
Teva Investigational Site 173
Nürnberg,
GermanySite Not Available
Teva Investigational Site 156
Oldenburg,
GermanySite Not Available
Teva Investigational Site 108
Pforzheim,
GermanySite Not Available
Teva Investigational Site 136
Pirmasens,
GermanySite Not Available
Teva Investigational Site 172
Prien am Chiemsee,
GermanySite Not Available
Teva Investigational Site 150
Rheine,
GermanySite Not Available
Teva Investigational Site 125
Rostock,
GermanySite Not Available
Teva Investigational Site 169
Saalfeld,
GermanySite Not Available
Teva Investigational Site 148
Schwalmstadt,
GermanySite Not Available
Teva Investigational Site 166
Schwerin,
GermanySite Not Available
Teva Investigational Site 126
Solingen,
GermanySite Not Available
Teva Investigational Site 128
Traunstein,
GermanySite Not Available
Teva Investigational Site 170
Trier,
GermanySite Not Available
Teva Investigational Site 175
Ulm,
GermanySite Not Available
Teva Investigational Site 162
Unna,
GermanySite Not Available
Teva Investigational Site 153
Velbert,
GermanySite Not Available
Teva Investigational Site 105
Warendorf,
GermanySite Not Available
Teva Investigational Site 115
Wesel,
GermanySite Not Available
Teva Investigational Site 140
Wetzlar,
GermanySite Not Available
Teva Investigational Site 120
Wiesbaden,
GermanySite Not Available
Teva Investigational Site 137
Worms,
GermanySite Not Available
Teva Investigational Site 161
Wuppertal,
GermanySite Not Available
Teva Investigational Site 103
Würzburg,
GermanySite Not Available
Teva Investigational Site 145
Zwiesel,
GermanySite Not Available
Teva Investigational Site 146
Zwiesel,
GermanySite Not Available
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