The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly

The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly - The efficacy and safety of ramelteon in prevention of postoperative delirium in the elderly

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007584

Enrollment

300

Registered

2012-05-01

Start date

2012-05-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

postoperative delirium

Interventions

Control group are received placebo capsule (lactose) 8mg before two hours at sleep time every night at least two weeks before operation day. Ramelteon 4mg group are received Ramelteon capsule 4mg befo

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients aged over 65 years scheduled for operation at Kobe University Hospital Hepato-biliary-pancreatic surgery.

Exclusion criteria

Exclusion criteria: 1 Patients with a history of hypersensitivity to this drug. 2 Patients with severe hepatic dysfunction. 3 Patients treated with Fluvoxamine maleate. 4 Patients judged to be unsuitable.

Design outcomes

Primary

Measure	Time frame
The primary outcome was the occurrence of delirium as determined by Confusion Assessment Methods-ICU (CAM-ICU) criteria at day 1,2,3,and 7 after operation.	—

Secondary

Measure	Time frame
The secondary outcome was the degree of severity of delirium as determined by Method Delirium Assessment Scale (MDAS) criteria if postoperative delirium occurs.	—

Countries

Japan

Contacts

Public ContactKyoichi Shiroiwa

Kobe University Hospital Psychiatry and Neurology

kyoichis@med.kobe-u.ac.jp078-382-6065

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026