postoperative delirium
Conditions
Interventions
Patients take 8 mg ramelteon for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1.
Patients take matching lactose for six nights, preoperative night and consec
Sponsors
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: American Society of Anesthesiologists physical status 1,2,or 3 and scheduled to undergo general surgery, urological surgery, vascular surgery, or chest surgery under general anesthesia.
Exclusion criteria
Exclusion criteria: Patients who are delirious on registry Patients who are currently taking ramelteon Patients who have a previous adverse reaction to ramelteon Patients who take medicine contraindicated to be coadministered with ramelteon Patients with lactose intolerance Patients who are considered non per os on postoperative day 1 Patients who are considered to be discharged within postoperative day 6 Patients who have a score less than or equal to 10 on the Mini Mental State Examination Patients who have severe hepatic damage Patients with known Dementia with Lewy bodies
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The difference in the incidence of delirium as determined by Diagnostic and Statistical Manual of Mental Disorders, version 5 criteria between the placebo and ramelteon groups from postoperative day 0 to 6 | — |
Countries
Japan
Contacts
Public ContactMariko Mariko
Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology Department of Anesthesiology
Outcome results
None listed