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. 2019 Sep 3;2019(9):CD011749. doi: 10.1002/14651858.CD011749.pub2

NCT02216266.

Trial name or title Monocentre, double‐blind, randomised, placebo‐controlled study to evaluate physostigmine for the treatment of delirium in perioperative intensive care medicine
Methods Single‐site, triple‐blind, randomized placebo‐controlled study taking place in Germany. Target enrolment: 120 participants
Participants Adult (18 to < 85 years) ICU patients post elective or emergency heart surgery (with or without extracorporeal circulation) diagnosed with delirium via the CAM‐ICU
Interventions Participants randomized to receive physostigmine or placebo, administered intravenously at a dose of 24 mg + 25 minutes at 0.04 mg/kg
Outcomes Primary
  1. Change in delirium symptoms measured by RASS


Secondary
  1. Duration of mechanical ventilation

  2. Change in spontaneous EEG and auditory evoked potential

  3. Heart rate variability

  4. Muscular force (via force gauge)

  5. Adverse events.

Starting date April 2014
Contact information Bertram Scheller (bertram.scheller@kgu.de)
Notes Study status unknown, but last updated as recruiting on 10 March 2017
Study sponsor: PD Dr Bertram Scheller
Study registered: at clinicaltrials.gov under NCT02216266