delirium
Conditions
Interventions
suvorexant 15 mg/day during ICU stay (for a maximum of 7 days)
placebo during ICU stay (for a maximum of 7 days)
Sponsors
Yokohama City University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients meeting the following requirements ? undergoing elective cardiac surgery using cardiopulmonary bypass and without circulatory arrest or selective cerebral perfusion ? admitted to ICU after surgery ? at high risk for / with symptoms of insomnia ? first-person consent to participation
Exclusion criteria
Exclusion criteria: Patients meeting any of the following criteria ? taking suvorexant at the time of enrollment ? taking ramelteon at the time of enrollment ? history of hypersensitivity to suvorexant ? taking a drug that is incompatible with suvorexant ? intracranial organic lesion ? diagnosed as dementia or scored 21 or less on Mini-Mental State Examination ? depression ? taking anti-psychotic drugs ? alcohol abuse ? severe renal dysfunction that requires maintenance dialysis (preoperatively) ? severe hepatic dysfunction (Child-Pugh class B or C) ? restriction in the evaluation of delirium using CAM-ICU in terms of impairment in communication (in Japanese) and/or physical disability
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| incidence of delirium determined by CAM-ICU (for a maximum of 7 days) after cardiac surgery in ICU | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of the number of times that a patient is deemed CAM-ICU positive to the total number of CAM-ICU assessment during ICU stay 2. Length of mechanical ventilation 3. Length of ICU stay 4. Length of hospital stay 5. Development of hyperactive delirium requiring psychiatric consultation or antipsychotic medication | — |
Countries
Japan
Contacts
Public ContactTakayuki Kariya
Yokohama City University Medical Center Intensive Care Department
Outcome results
None listed