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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-004082-41 | EudraCT Number |
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| Name | Class |
|---|---|
| Goethe University | OTHER |
| Dr. Franz Köhler Chemie GmbH (study medication and labeling) | UNKNOWN |
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Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physostigmine | Active Comparator | Physostigmine administered intravenously at a dose of 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram |
|
| Sodium Chloride solution | Placebo Comparator | solution administered intravenously 24 mg + 25 min a 0,04 mg/kg milligram(s)/kilogram |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Physostigmine | Drug |
|
| |
| Sodium Chloride solution |
| Measure | Description | Time Frame |
|---|---|---|
| change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS) | baseline to 48 hours after administration |
| Measure | Description | Time Frame |
|---|---|---|
| reduction of weaning time at mechanical ventilator of patients with symptoms of delirium | baseline to 48 hours after administration | |
| change in the spontaneous EEG and auditory evoked potentials | for the spontaneous EEG, we expect a shift in the frequency characteristics, measure is the spectrogram, more precisely the amplitude per frequency (band) and the phase information derived via Fourier Transform and Wavelet transformation The paradigm of the auditory stimulation is a roving paradigm (Science 13 May 2011: Vol. 332 no. 6031 pp. 858-862 DOI: 10.1126/science.1202043 •Report Preserved Feedforward But Impaired Top-Down Processes in the Vegetative State Melanie Boly1,2,*, Marta Isabel Garrido2, Olivia Gosseries1, Marie-Aurélie Bruno1, Pierre Boveroux3, Caroline Schnakers1, Marcello Massimini4, Vladimir Litvak2, Steven Laureys1, Karl Friston2) Measures will be differences in the mismatch negativity and in the phase synchronization between electrodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bertram Scheller, MD | Contact | bertram.scheller@kgu.de |
| Name | Affiliation | Role |
|---|---|---|
| Bertram Scheller, MD | Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy of Goethe-University Frankfurt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy | Recruiting | Frankfurt | Hessia | 60590 | Germany |
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| Other |
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| baseline to 48 hours after administration |
| impact of the variability of heart rate | heart rate variability is a dimensionless parameter, assessing the variability of the heart rate from ECG measures (Heart Rate Variability Conny M. A. van Ravenswaaij-Arts, MD; Louis A. A. Kollee, MD, PhD; Jeroen C. W. Hopman, MSc; Gerard B. A. Stoelinga, MD, PhD; and Herman P. van Geijn, MD, PhD [+-] Article and Author Information Ann Intern Med. 1993;118(6):436-447. doi:10.7326/0003-4819-118-6-199303150-00008 ) | baseline to 48 hours |
| change in development of muscular force | muscular force is measured with a force gauge, measured in [Newton] | baseline up to 48 hours |
| Occurence of Adverse events | baseline to 4 weeks after treatment |
| ID | Term |
|---|---|
| D003693 | Delirium |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D010830 | Physostigmine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D048448 | Phenylcarbamates |
| D002219 | Carbamates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D026121 | Indole Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D054836 | Indolizidines |
| D007212 | Indolizines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
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