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 range
18 Years – 85 Years
Sex
ALL
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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