Status:
UNKNOWN
Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery
Lead Sponsor:
PD Dr. Bertram Scheller
Collaborating Sponsors:
Goethe University
Dr. Franz Köhler Chemie GmbH (study medication and labeling)
Conditions:
Suspected Delirium After Elective or Emergency Heart Surgery
CAM-ICU Diagnosed Delirium
Eligibility:
All Genders
18-85 years
Phase:
PHASE3
Brief Summary
Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery
Eligibility Criteria
Inclusion
- Patients of both genders aged \> 18 years, \< 85 years of ICU C1 after elective or emergency heart 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
Exclusion
- Asthma
- hypersensitivity against Physostigmine salicylate, Sodium metabisulfite, 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 children, pregnancy or nursing
- patients with addictive disorder in medical history
Key Trial Info
Start Date :
April 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2018
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT02216266
Start Date
April 1 2014
End Date
December 1 2018
Last Update
March 10 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy
Frankfurt, Hessia, Germany, 60590