The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly : RCT
- Conditions
- postoperative delirium
- Registration Number
- JPRN-jRCTs031180054
- Lead Sponsor
- Ogura Makoto
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 108
American Society of Anesthesiologists physical status 1,2,or 3 and scheduled to undergo general surgery, urological surgery, vascular surgery, or thoracic surgery under general anesthesia
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.
- Secondary Outcome Measures
Name Time Method