Parent study
delirium, delirious, Confusion
Detailed methods of the randomized control trial are published elsewhere, and a flow diagram for the current study that also includes patient enrollment from the original study is shown in Fig. Participant flow diagram. 120 participants were randomized as part of the original clinical trial. There were 97 patients include in the actigraphy analysis presented here.After enrollment, participants were randomized in a 4-factor blocked fashion to receive either ramelteon 8 mg or matching placebo each evening at 9 p.m. starting the night prior to surgery (post-operative day-1, or POD-1) and for a maximum of six additional nights (POD 5), or until discharge from the ICU, whichever occurred first. In addition to obtaining daily clinical data, patients were assessed for delirium twice daily using the Confusion Assessment Method ICU (CAM-ICU) through POD 8. Those not scored as CAM-ICU positive (CAM+) on any assessment are termed “never delirious,” while those with at least one CAM + assessment are termed “delirious.” Investigators, subjects, and other clinical care providers remained blinded to drug assignment until trial completion and all data collection was complete.