E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
patients with delirium in perioperative intensive care medicine |
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E.1.1.1 | Medical condition in easily understood language |
patients with delirium in perioperative intensive care medicine |
Patienten mit intensivmedizinischen Delir |
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E.1.1.2 | Therapeutic area | Body processes [G] - Bones and nerves physological processes [G11] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 17.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10012221 |
E.1.2 | Term | Deliria (incl confusion) |
E.1.2 | System Organ Class | 10037175 - Psychiatric disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Improvement of vigilance or symptoms of the delirum after administration of physostigmin measured by Richmond Agitation Sedation Score (RASS). |
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E.2.2 | Secondary objectives of the trial |
a) reduction of weaning time at mechanical ventilator of patients with symptoms of delirium b) impact on the spontaneous EEG and auditory evoked potentials c) impact of the variability of heart rate d) impact of development of muscular force
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients of both genders aged > 18 years, < 85 years of ICU C1 after elective or emergency cardio surgery with or without extracorporeal circulation (heart–lung machine and/or extracorporeal membrane oxygenation), with suspected delirium. (May be suspected if a patient does not show adequate improvement of vigilance 24 h after adequate reduction or stop of sedative medicine) - Patients (>18a, <85a) with CAM-ICU diagnosed delirium - Patients of legal capacity and patients with appointed representative or informed consent of an independet consultant |
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E.4 | Principal exclusion criteria |
- Asthma - hypersensitivity against Physostigminsalicylat, Sodium metabisulfit, Nitrogen - gangrene - mechanical obstipation - mechanical urinary retention - Dystrophia myotonica - Depolarization block after depolarising muscle relaxants - Intoxications with „irreversibly acting“ cholinesterase inhibitors - closed head trauma - obstructions at gastro-intestinal tract and at urinary tract - neurological diseases - left ventricular ejection fraction < 40% - Simultaneous Participation in other clinical trials or participation ind other clinical trials in the last 30 days - untreated coronary heart disease - wish to have chirldren, pregnancy or nursing - patients with addicitve disorder in medical history
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E.5 End points |
E.5.1 | Primary end point(s) |
Improvement of vigilance or symptoms of the delirum after administration of physostigmin measured by Richmond Agitation Sedation Score (RASS). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
30 minutes, 2 , 24 and 48 hours and 4 weeks after begin of administration of IMP/placebo |
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E.5.2 | Secondary end point(s) |
reduction of weaning time at mechanical ventilator of patients with symptoms of delirium impact on the spontaneous EEG and auditory evoked potentials impact of the variability of heart rate impact of development of muscular force |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
30 minutes, 2 , 24 and 48 hours and 4 weeks after begin of administration of IMP/placebo |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | No |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |