Outcomes
delirium, delirium-, anxiety, movement disorders, comatose, hallucinations, agitation, post-traumatic stress disorder, coma, muscle rigidity, PTSD, depression
MOVEMENT DISORDERS, COMATOSE, SECONDARY, COMA, EVENTS
The primary outcome was the number of delirium- and coma-free days (DCFDs) while alive and admitted to the ICU up to 14 days after randomization. A delirium day was defined as at least one positive delirium assessment on that calendar day where the RASS score was ≥ − 3. A patient was considered to be comatose when any RASS score on that day was − 4 or − 5 in the absence of documented delirium or if delirium was indicated to be not assessable due to coma [All outcomes refer to the 14-day intervention period, which started after randomization. Predefined secondary outcomes were daily RASS scores, maximum mobility level, sleep quality, use of “escape medication” for hallucinations and/or agitation (including atypical antipsychotics, alpha-2 agonists [clonidine and dexmedetomidine], GABA agonists [benzodiazepines and propofol], opiates and ‘open-label’ haloperidol), daily study drug dose corrected for body weight (mg/kg), self-extubation rate and patient-initiated removal of invasive devices, (serious) adverse drug associated events (prolonged QTc by EKG, muscle rigidity and other associated movement disorders [Simpson Angus Scale] [We also assessed the following prospectively collected post hoc exploratory outcomes: number of days with study drug administration, and number of days with delirium, coma, agitation (defined as a RASS score + 2 or more at least once on that day[Secondary predefined long-term outcomes after hospital discharge were patient and family member memories and experiences at hospital discharge and 3 months after randomization, post-traumatic stress disorder (PTSD) symptoms and burden experienced by the family at 3 months after randomization, anxiety, depression, cognition, and quality of life at 3 and 12 months after randomization, and 12-month mortality.Data collection and definitions of all subgroup analyses and outcomes are described in detail in Additional file 