Evaluation if physostigmin reduces symptoms in patients who has developed a delirium in Intensive care after a surgery
- Conditions
- patients with delirium in perioperative intensive care medicineMedDRA version: 17.1Level: HLGTClassification code 10012221Term: Deliria (incl confusion)System Organ Class: 10037175 - Psychiatric disordersTherapeutic area: Body processes [G] - Bones and nerves physological processes [G11]
- Registration Number
- EUCTR2012-004082-41-DE
- Lead Sponsor
- Dekan of Faculty of Medicine of Goethe-University Frankfurt
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 120
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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 60
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method