A phase II study of ramelteon on preventive of postoperative delirium after gastrectomy in elderly patinet

A phase II study of ramelteon on preventive of postoperative delirium after gastrectomy in elderly patinet - A phase II study of ramellteon on preventive of postoperative delirium

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000018697

Enrollment

Registered

2015-08-17

Start date

2015-08-17

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

Gastric cnacer

Interventions

Ramelteon 8mg/day is administered after dinner from 7 days to previous day before operation. Ramelton is also administered after operation from initiation of drinking water to discharge.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Histologically proven adenocarcinoma of the stomach. 2.Gastrectomy, not partial resection, is planned. 3. Age is greater than or equal to 75 years old. 4. Eeatern clinical oncology group performance status is 0 or 1. 5.Oral administration is possible without signs of bowel obstruction nor bleeding. 6. Adequate organ function satisfying following criteria. WBC > 3,000/mm3 Plt > 100,000/mm3 AST < 100 IU/L ALT < 100IU/L T.Bil < 2.0 g/dl Cre < 1.5mg/dl 7. Given written informed consent.

Exclusion criteria

Exclusion criteria: 1. Diagnosed as dementia. 2. Psychiatric disorder including alcoholism. 3. Regular use of steroids or opioid. 4. With a history of hypersensitivity to ramelteon. 5. Treated with Fluvoxamine meleate.

Design outcomes

Primary

Measure	Time frame
Incidence of postoperative delirium	—

Countries

Japan

Contacts

Public ContactHonda Shinsaku

Shizuoka Cancer Center Division of Gastric Surgery

sh.honda@scchr.jp055-989-5222

Outcome results

None listed

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