The efficacy of ramelteon to prevent postoperative delirium after general anesthesia in the elderly : RCT

JRCT ID: jRCTs031180054

Registered date:12/12/2018

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: postoperative delirium
• Date of first enrollment: 19/09/2017
• Target sample size: 108
• Study type: Interventional

Intervention(s)

Intervention: Patients take 8 mg ramelteon for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1.
Control: Patients take matching lactose for six nights, preoperative night and consecutive 5 nights, beginning on postoperative day 1.

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 65age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: 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

Exclude 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

Related Information

• Primary Sponsor: Ogura Makoto
• Source(s) of Monetary Support: Tokyo Metropolitan Geriatric Hospital and Institute of Gerontology
• Secondary ID(s): R000032553