Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensiv… (NCT02216266) | Clinical Trial Compass
UnknownPhase 3
Evaluation if Physostigmine Reduces Symptoms in Patients Who Has Developed a Delirium in Intensive Care After a Surgery
Germany120 participantsStarted 2014-04
Plain-language summary
Evaluation if physostigmine reduces symptoms in patients who has developed a delirium in Intensive care after a surgery
Who can participate
Age range18 Years – 85 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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
What they're measuring
1
change of vigilance or symptoms of the delirium measured by Richmond Agitation Sedation Score (RASS)
Timeframe: baseline to 48 hours after administration