Influence of Dexmedetomidine or Propofol on ICU Delirium (NCT02807467) | Clinical Trial Compass
TerminatedPhase 4
Influence of Dexmedetomidine or Propofol on ICU Delirium
Stopped: insufficient recruitment over a long period
Switzerland37 participantsStarted 2019-03-01
Plain-language summary
In this randomized study, the investigators aim to test the hypothesis that the reinstitution of a normal circadian rhythm by continuous infusions of dexmedetomidine compared to propofol between 8pm and 6am after diagnosis of hyperactive or mixed delirium, decreases the duration of delirium. The infusions might have to be repeated several times to achieve resolution of delirium.
Who can participate
Age range
18 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:
* Adult patients (age 18 years or older) in a state of delirium (hyperactive ore mixed type) upon detection in the ICU (i.e., ICDSC \>3).
Exclusion Criteria:
* Hypersensitivity to the active substance
* Advanced heart block (grade 2 or 3) unless implanted pacemaker
* Uncontrolled hypotension
* Severe cardiac dysfunction
* Bradycardia
* Egg allergy
* Soybean/soy allergy
* Age below 18 years
* Terminal state
* Pregnancy
* Active psychosis (of non organic origin = functional disturbances)
* Status epilepticus or postictal states following seizures on EEG
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
Reduction of ICU delirium duration assessed by ICDSC checklist
Timeframe: during stay at ICU, an average of 3 days; Delirium duration assessed every 8 hours starting with patient's ICU admission until delirium has subsided