| Conditions: |
Delirium; Agitation |
| Interventions: |
Drug: Risperidone; Drug: Trazodone; Drug: Placebo |
| Outcome Measures: |
The number of days patients are without delirium during the study period (delirium-free days); Daily prevalence of delirium as indicated by a positive Confusion Assessment Method in the ICU (CAM-ICU); Resolution of delirium as indicated by a negative Confusion Assessment Method in the ICU (CAM-ICU) for more than 24 hours; The number of patients who require rescue medications, the type of rescue medications utilized, and the amount of rescue medications per day; The number of patients who receive sedative agents, amount of midazolam equivalents per day, and the number of days in which patients receive a sedative agent; The number of patients who receive pain medications, amount of fentanyl equivalents per day, and the number of days in which patients receive a pain medication; The number of hours spent agitated (RASS score between +4 and +2) as a percent of the time that the study drug was administered; The number of hours spent excessively sedated or in a coma state (RASS score between -4 to -5) as a percent of the time that the study drug was administered; The duration of mechanical ventilation from initial intubation to extubation as long as the patient remained extubated for more than 48 hours.; The number of days that the patients were alive and breathing without assistance during the study period (ventilator-free days); The number of episodes and number of patients who experience clinically significant QTc prolongation (≥ 500 msec or an increase of more than 60 msec from baseline); The number of episodes and number of patients who experience clinically significant extrapyramidal effects (as evidenced by a positive Simpson-Angus Scale Score); All-cause mortality and 28-day mortality |
