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 range18 Years

SexALL

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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

What they're measuring

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

Trial details

NCT IDNCT02807467

SponsorUniversity Hospital, Basel, Switzerland

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-03-03

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